Cancer, RectalAMIREMBOL_2NCT06236633
Safety & Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Surgery for Tumors of Lower and Middle Rectum
A study testing Ischemic preconditioning and Arteriogram in people with Cancer, Rectal, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
The present study will investigate the safety of inferior mesenteric artery embolization prior to rectal surgery, according to IDEAL recommendations (Lancet 2009). It aims to assess the safety of endovascular embolization of the inferior mesenteric artery prior to surgery in patients with rectal tumors, and estimate… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer, Rectal
- What is being tested?
- Ischemic preconditioning and Arteriogram
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Aug 2024to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rectal cancer eligible for surgery with ligation at the origin of the inferior mesenteric artery.
- Patients with free, informed consent.
- Patients affiliated to or benefiting from a health insurance plan.
Who cannot join
- Patients with a history of colon cancer who has undergone colon resection surgery
- Patients with occlusion of the superior mesenteric artery or stenosis of more than 50%, visible on the CT scan performed as part of conventional management during extension workup.
- Patients with occlusion of the IMA on the extension scan.
- Patients with a systemic disorder responsible for haemostasis (haemophilia, Willebrand's disease, thrombocytopenia) and on anticoagulant therapy.
- Patients taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk.
- Patients with renal insufficiency with clearance < 30mL/min.
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- Patients with an allergy to iodine.
- Patients who has had treatment of the abdominal aorta or its branches.
- Patients participating in an interventional study.
- Patients in an exclusion period determined by another study.
- Patients under court protection, guardianship or curatorship.
- Patients unable to give consent.
- Patients for whom it is impossible to provide informed information.
- Pregnant or breast-feeding patients.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hôpital Saint-Eloi
Montpellier, 34295
Boris GUIU, Pr
Boris GUIU, Pr
- Recruiting
Institut du Cancer de Montpellier
Montpellier, 34298
Philippe ROUANET, Pr
Philippe ROUANET, Pr
- Recruiting
CHU de Nîmes
Nîmes, 30029
Martin BERTRAND, Pr
Martin BERTRAND, Pr
About this study
Official title: Evaluation of the Safety and Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Oncologic Surgery for Tumors of the Lower and Middle Rectum. Bicentric Exploratory Pilot Study
The present study will investigate the safety of inferior mesenteric artery embolization prior to rectal surgery, according to IDEAL recommendations (Lancet 2009). It aims to assess the safety of endovascular embolization of the inferior mesenteric artery prior to surgery in patients with rectal tumors, and estimate the potential benefits in terms of time to surgery and the occurrence of post-operative fistulas.The study will also assess the impact of subacute ischemia induced by IMA embolization on colonic vasculature remodeling, colonic ischemic suffering, altered hemostasis and initiation of neo-angiogenesis through blood sampling kinetics.The hypothesis is that ischemic preconditioning by inferior mesenteric artery embolization prior to rectal cancer resection surgery is safe and will result in a decrease in acute relative colon ischemia and a reduction in the rate of fistulas and post-surgical complications. Indeed, we believe that the beneficial effects of the ischemic preconditioning of IMA will be due to better blood perfusion of the colon at 3 weeks, which is apparently linked to remodeling and/or the development of collateral vascularization.
Read the detailed description
Anastomotic fistulas are the main cause of morbidity and mortality in colorectal surgery. They are responsible for septic complications, leading to increased mortality, local recurrence, repeat surgery and impaired sexual, urinary and digestive function. Fistulas are multifactorial; among the causes, colonic vascularization seems to be a major one. Ligation of the inferior mesenteric artery during rectal surgery has been shown to reduce intraoperative colonic perfusion flow. The left colon is then vascularized only by the colonic border arcade, perfused by the superior mesenteric artery. Ischemic pre-conditioning of the arterial network prior to surgery should ensure better vascularization by developing arterial collaterality and increasing perfusion flow in the colonic border arcade. In view of major advances in interventional radiology, this preconditioning could be achieved by endovascular ligation of the inferior mesenteric artery (IMA), based on the same principle as during surgery: proximal occlusion of the inferior mesenteric artery (IMA), using embolization material (plug or coils), 3 weeks before surgery, to allow the colonic border arcade to develop. We carried out a single-center pilot study (AMIREMBOL 1, NIMAO 2017; Frandon et al. 2022) to assess the feasibility of ischemic preconditioning of the colon for patients with rectal or sigmoid cancer. The study included 10 patients, randomized into two groups: the control group, with preoperative arteriography and standard management and the "embolization" group, with embolization of the IMA three weeks prior to surgery. IMA embolization was successfully performed in all 5 patients in the embolization group, with no major complications. The effect on colonic perfusion, measured by intraoperative Doppler directly on the border arch, with recording of resistance indexes (independent of measurement angle), showed a drop in resistance indexes in the control arm, after ligation of the IMA, which persisted after 5 minutes. In the "Embolization" arm, no drop in this index was reported during surgery, reflecting good development of vascular collaterality and at least relative acute ischemia of the colon after IMA ligation during surgery. Finally, in the "control" group, one anastomotic fistula was reported after surgery and required re-operation. There were no fistulas in the embolization group.
The present study (AMIREMBOL 2) will investigate the safety of IMA embolization prior to rectal surgery, according to IDEAL recommendations (Lancet 2009). Its aim is to assess the safety of endovascular embolization of the IMA prior to surgery in patients with rectal tumors, and to estimate the potential benefits in terms of time to surgery and the occurrence of post-operative fistulas.
The study will also assess the impact of subacute ischemia induced by IMA embolization on colonic vasculature remodeling, colonic ischemic suffering, altered hemostasis and initiation of neo-angiogenesis through blood sampling kinetics.
The hypothesis is that ischemic preconditioning by inferior mesenteric artery (IMA) embolization prior to rectal cancer resection surgery is safe and will result in a decrease in acute relative colon ischemia and a reduction in the rate of fistulas and post-surgical complications. The hypothesis is that the beneficial effects of the ischemic preconditioning of IMA will be due to better blood perfusion of the colon at 3 weeks, which is apparently linked to remodeling and/or the development of collateral vascularization.
- Conditions
- Cancer, Rectal
- Being tested
- Ischemic preconditioning, Arteriogram
- Keywords
- Ischemic preconditioning surgery, Cancer, Rectal, Inferior Mesenteric Artery Embolus
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic preconditioningProcedure or surgery
Embolization performed via a common right femoral or radial approach, depending on the patient's conformation. Minor complications such as hematoma at the puncture site are rare in less than 1% of cases, and serious complications are exceptional. Proximal occlusion of the inferior mesenteric artery, before its dividing branches, using material adapted to arterial occlusion according to anatomical findings. Proximal occlusion during embolization is evaluated by intravascular injection into the inferior mesenteric artery, and resumption of vascularization of the distal inferior mesenteric artery is controlled by the border arcade injecting into the superior mesenteric artery. In the event of a high-risk anatomical variant, or absence of a border arcade, no embolization will be performed and the patient will be excluded from the study; this will represent no more than 1-2% of patients (surgical series describing 0.83% of ischemia in connection with absence of a border arcade).
ArteriogramProcedure or surgery
The interventional radiologist performs an arteriogram of the inferior and superior mesenteric arteries (IMA and SMA respectively) to check that the SMA is free of anomalies and that the IMA has a proximal trunk long enough for embolization. The radiologist also checks for the presence of a colonic border arcade. If this is absent, embolization will not be performed: the patient will be excluded from the study.This arteriogram is carried out under local anaesthetic specifically for research purposes, as follows: Common right femoral or radial approach and placement of a small introducer. Selective arteriogram of the inferior and superior mesenteric arteries to check perfusion of the border arcade.Arterial closure system or manual compression. Return to surgery or interventional radiology department. Patient discharged the same day after medical assessment (surgeon or interventional radiologist).Telephone check-up on Day1 (standard management) and Day 7 (added as part of the protocol).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | In the control group, patients will undergo standard management. |
| Ischemic preconditioning group | Experimental | In the experimental group, patients will undergo preoperative arteriography and ischemic preconditioning One blood sample will be taken before and two samples taken after embolization of the IMA.
These patients will receive a phone call on Day 7 post embolization. A blood sample will also be taken at the time of surgery. Receives: Procedure: Ischemic preconditioning; Procedure: Arteriogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of endovascular inferior mesenteric artery embolisation prior to surgical resection of the rectum in patients with tumours of the lower and middle rectum.
Percentage of patients with a complication (any grade) within 7 days after embolisation of the inferior mesenteric artery according to the classification of the International Society of Interventional Radiology assessed during the follow-up telephone consultation by the interventional radiologist.
Complications will be classified as minor (Grades A and B) or Major (grades C to F).
Grade A = No therapy, no consequence Grade B = Nominal therapy, no consequence. Includes overnight admission for observation only Grade C = Requires therapy, minor hospitalization (<48 hours) Grade D = Requires major therapy. Unplanned increase in level of care. Prolonged hospitalization (>48 hours) Grade E = Permanent adverse sequelae Grade F= Death
Measured: Day 7 post embolization (performed 3 weeks before surgical resection of the rectum)
Secondary outcomes (96)
Technical success of the embolization procedure
A control arteriogram of the inferior and superior mesenteric arteries will be carried out at the end of the embolisation procedure: intravascular injection into the inferior mesenteric artery and control of the resumption of vascularisation of the distal inferior mesenteric artery by the border arcade by injecting into the superior mesenteric artery.
If embolisation fails, the patient will continue the study.
The number of failures will be converted into a percentage
Measured: Day 0, on the day of embolization
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade I
Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.
The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)
Measured: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade II
Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.
The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)
Measured: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IIIa
Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.
The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)
Measured: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IIIb
Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.
The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)
Measured: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IVa
Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.
The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)
Measured: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IVb
Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.
The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)
Measured: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade V
Percentage of patients presenting a post-operative complication according to the Clavien-Dindo Classification within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.
The Clavien-Dindo classification (Dindo et al 2004, Dindo D. 2004) classifies surgical complications into 7 categories (I, II, IIIa, IIIb, IVa, IVb and V)
Measured: Post-operative Day 30
Rate of fistulas up to 30 days after surgery
Percentage of patients with a fistula within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.A fistula will be identified either on the basis of clinical criteria (presence of pus or enteric contents in the drains, leakage of contrast medium through the anastomosis, anastomotic dehiscence during a repeat operation), or on the basis of radiological criteria (presence of an abdominal or pelvic collection in the area of the anastomosis on CT scan) if there is clinical doubt or if a CT scan is carried out for another reason (before stoma closure, for example).
Measured: Day 0
Rate of fistulas up to 30 days after surgery
Percentage of patients with a fistula within 30 days of rectal surgery, assessed during hospitalization and at the 1-month post-surgical consultation, according to standard management.A fistula will be identified either on the basis of clinical criteria (presence of pus or enteric contents in the drains, leakage of contrast medium through the anastomosis, anastomotic dehiscence during a repeat operation), or on the basis of radiological criteria (presence of an abdominal or pelvic collection in the area of the anastomosis on CT scan) if there is clinical doubt or if a CT scan is carried out for another reason (before stoma closure, for example).
Measured: Post-operative Day 30
Duration of post-surgical hospitalization
Length of hospital stay (number of days)
Measured: Up to 30 days after rectal surgery
Degree of difficulty experienced by the visceral surgeon during surgery
Surgeon's assessment of degree of difficulty using a 4-point Likert scale after each operation as follows :
1= Dissection of the inferior mesenteric artery was standard 2 = Dissection of the inferior mesenteric artery was more complicated than expected 3 = Dissection of the inferior mesenteric artery was much more complicated than expected; 4 = Dissection of the inferior mesenteric artery was Very difficult.
Measured: Week 3 to 4 on the day of rectal surgery
Systemic inflammation markers: Pro-inflammation cytokines
Pro-inflammation cytokines (IL-1β, IL-6, IL-8, Tumor Necrosis Factor-α and Interferon-ɣ) will be measured as percentages
Measured: Day 0 (on the day of inclusion)
Systemic inflammation markers: Pro-inflammation cytokines
Pro-inflammation cytokines (IL-1β, IL-6, IL-8, Tumor Necrosis Factor-α and Interferon-ɣ) will be measured as percentages
Measured: 25 minutes before embolization
Systemic inflammation markers: Pro-inflammation cytokines
Pro-inflammation cytokines (IL-1β, IL-6, IL-8, Tumor Necrosis Factor-α and Interferon-ɣ) will be measured as percentages
Measured: 60 minutes after embolization
Systemic inflammation markers: Pro-inflammation cytokines
Pro-inflammation cytokines (IL-1β, IL-6, IL-8, Tumor Necrosis Factor-α and Interferon-ɣ) will be measured as percentages
Measured: Week 3 to 4 after patient induction just before rectal surgery
Systemic inflammation markers: Complement protein C3
Complement protein C3 will be measured as a percentage
Measured: Day 0 (on the day of inclusion)
Systemic inflammation markers: Complement protein C3
Complement protein C3 will be measured as a percentage
Measured: 25 minutes before embolization
Systemic inflammation markers: Complement protein C3
Complement protein C3 will be measured as a percentage
Measured: 60 minutes after embolization
Systemic inflammation markers: Complement protein C3
Complement protein C3 will be measured as a percentage
Measured: Week 3 to 4 after patient induction just before rectal surgery
Anti-inflammation markers:
IL-10 and Transforming Growth Factor-β will be measured as percentages
Measured: Day 0 (on the day of inclusion)
Anti-inflammation markers:
IL-10 and Transforming Growth Factor-β will be measured as percentages
Measured: 25 minutes before embolization
Anti-inflammation markers:
IL-10 and Transforming Growth Factor-β will be measured as percentages
Measured: 60 minutes after embolization
Anti-inflammation markers:
IL-10 and Transforming Growth Factor-β will be measured as percentages
Measured: Week 3 to 4 after patient induction just before rectal surgery
Hemostasis markers : Von Willebrand factor
Von Willebrand factor will be measured.
Measured: Day 0 (on the day of inclusion)
Hemostasis markers : Von Willebrand factor
Von Willebrand factor will be measured.
Measured: 25 minutes before embolization
Hemostasis markers : Von Willebrand factor
Von Willebrand factor will be measured.
Measured: 60 minutes after embolization
Hemostasis markers : Von Willebrand factor
Von Willebrand factor will be measured.
Measured: Week 3 to 4 after patient induction just before rectal surgery
Hemostasis markers : coagulation factor V
Coagulation factor V will be measured.
Measured: Day 0 (on the day of inclusion)
Hemostasis markers : coagulation factor V
Coagulation factor V will be measured.
Measured: 25 minutes before embolization
Hemostasis markers : coagulation factor V
Coagulation factor V will be measured.
Measured: 60 minutes after embolization
Hemostasis markers : coagulation factor V
Coagulation factor V will be measured.
Measured: Week 3 to 4 after patient induction just before rectal surgery
Hemostasis markers : D-dimers
D-dimers will be measured
Measured: Day 0 (on the day of inclusion)
Hemostasis markers : D-dimers
D-dimers will be measured
Measured: 25 minutes before embolization
Hemostasis markers : D-dimers
D-dimers will be measured
Measured: 60 minutes after embolization
Hemostasis markers : D-dimers
D-dimers will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Hemostasis markers : platelet-activating factor (PAF)
Platelet-activating factor (PAF) will be measured
Measured: Day 0 (on the day of inclusion)
Hemostasis markers : platelet-activating factor (PAF)
Platelet-activating factor (PAF) will be measured
Measured: 25 minutes before embolization
Hemostasis markers : platelet-activating factor (PAF)
Platelet-activating factor (PAF) will be measured
Measured: 60 minutes after embolization
Hemostasis markers : platelet-activating factor (PAF)
Platelet-activating factor (PAF) will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Hemostasis markers : prostaglandin E4
Prostaglandin E4 will be measured
Measured: Day 0 (on the day of inclusion)
Hemostasis markers : prostaglandin E4
Prostaglandin E4 will be measured
Measured: 25 minutes before embolization
Hemostasis markers : prostaglandin E4
Prostaglandin E4 will be measured
Measured: 60 minutes after embolization
Hemostasis markers : prostaglandin E4
Prostaglandin E4 will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Hemostasis markers : Thromboxane B2
Thromboxane B2 will be measured.
Measured: Day 0 (on the day of inclusion)
Hemostasis markers : Thromboxane B2
Thromboxane B2 will be measured.
Measured: 25 minutes before embolization
Hemostasis markers : Thromboxane B2
Thromboxane B2 will be measured.
Measured: 60 minutes after embolization
Hemostasis markers : Thromboxane B2
Thromboxane B2 will be measured.
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of tissue inflammation: Blood pH
Blood pH will be measured
Measured: Day 0 (on the day of inclusion)
Markers of tissue inflammation: Blood pH
Blood pH will be measured
Measured: 25 minutes before embolization
Markers of tissue inflammation: Blood pH
Blood pH will be measured
Measured: 60 minutes after embolization
Markers of tissue inflammation: Blood pH
Blood pH will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of tissue inflammation: ischemia-modified albumin
Ischemia-modified albumin will be measured
Measured: Day 0 (on the day of inclusion)
Markers of tissue inflammation: ischemia-modified albumin
Ischemia-modified albumin will be measured
Measured: 25 minutes before embolization
Markers of tissue inflammation: ischemia-modified albumin
Ischemia-modified albumin will be measured
Measured: 60 minutes after embolization
Markers of tissue inflammation: ischemia-modified albumin
Ischemia-modified albumin will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP)
intestinal fatty acid-binding protein (I-FABP) will be measured
Measured: Day 0 (on the day of inclusion)
Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP)
intestinal fatty acid-binding protein (I-FABP) will be measured
Measured: 25 minutes before embolization
Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP)
intestinal fatty acid-binding protein (I-FABP) will be measured
Measured: 60 minutes after embolization
Markers of tissue inflammation:intestinal fatty acid-binding protein (I-FABP)
intestinal fatty acid-binding protein (I-FABP) will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of tissue inflammation: L-lactate
L-lactate will be measured
Measured: Day 0 (on the day of inclusion)
Markers of tissue inflammation: L-lactate
L-lactate will be measured
Measured: 25 minutes before embolization
Markers of tissue inflammation: L-lactate
L-lactate will be measured
Measured: 60 minutes after embolization
Markers of tissue inflammation: L-lactate
L-lactate will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of tissue inflammation: D-lactate
D-lactate will be measured
Measured: Day 0 (on the day of inclusion)
Markers of tissue inflammation: D-lactate
D-lactate will be measured
Measured: 25 minutes before embolization
Markers of tissue inflammation: D-lactate
D-lactate will be measured
Measured: 60 minutes after embolization
Markers of tissue inflammation: D-lactate
D-lactate will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of tissue inflammation: Lactate dehydrogenase
Lactate dehydrogenase will be measured
Measured: Day 0 (on the day of inclusion)
Markers of tissue inflammation: Lactate dehydrogenase
Lactate dehydrogenase will be measured
Measured: 25 minutes before embolization
Markers of tissue inflammation: Lactate dehydrogenase
Lactate dehydrogenase will be measured
Measured: 60 minutes after embolization
Markers of tissue inflammation: Lactate dehydrogenase
Lactate dehydrogenase will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of neoangiogenesis : CD34
CD34 will be measured
Measured: Day 0 (on the day of inclusion)
Markers of neoangiogenesis : CD34
CD34 will be measured
Measured: 25 minutes before embolization
Markers of neoangiogenesis : CD34
CD34 will be measured
Measured: 60 minutes after embolization
Markers of neoangiogenesis : CD34
CD34 will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of neoangiogenesis : transcription factor HIF1-α
Transcription factor HIF1-α will be measured
Measured: Day 0 (on the day of inclusion)
Markers of neoangiogenesis : transcription factor HIF1-α
Transcription factor HIF1-α will be measured
Measured: 25 minutes before embolization
Markers of neoangiogenesis : transcription factor HIF1-α
Transcription factor HIF1-α will be measured
Measured: 60 minutes after embolization
Markers of neoangiogenesis : transcription factor HIF1-α
Transcription factor HIF1-α will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of neoangiogenesis : Growth factors
Growth factors and their receptors, notably vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor (FGF) and fibroblast growth factor receptor (FGFR) and platelet-derived growth factor (PDGF) and platelet-derived growth factor receptor (PDGFR) will be measured
Measured: Day 0 (on the day of inclusion)
Markers of neoangiogenesis : Growth factors
Growth factors and their receptors, notably vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor (FGF) and fibroblast growth factor receptor (FGFR) and platelet-derived growth factor (PDGF) and platelet-derived growth factor receptor (PDGFR) will be measured
Measured: 25 minutes before embolization
Markers of neoangiogenesis : Growth factors
Growth factors and their receptors, notably vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor (FGF) and fibroblast growth factor receptor (FGFR) and platelet-derived growth factor (PDGF) and platelet-derived growth factor receptor (PDGFR) will be measured
Measured: 60 minutes after embolization
Markers of neoangiogenesis : Growth factors
Growth factors and their receptors, notably vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor (FGF) and fibroblast growth factor receptor (FGFR) and platelet-derived growth factor (PDGF) and platelet-derived growth factor receptor (PDGFR) will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2
Matrix metallo-protease - 2 will be measured
Measured: Day 0 (on the day of inclusion)
Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2
Matrix metallo-protease - 2 will be measured
Measured: 25 minutes before embolization
Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2
Matrix metallo-protease - 2 will be measured
Measured: 60 minutes after embolization
Markers of epithelial-mesenchymal transition : matrix metallo-protease - 2
Matrix metallo-protease - 2 will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9
Matrix metallo-protease - 9 will be measured
Measured: Day 0 (on the day of inclusion)
Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9
Matrix metallo-protease - 9 will be measured
Measured: 25 minutes before embolization
Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9
Matrix metallo-protease - 9 will be measured
Measured: 60 minutes after embolization
Markers of epithelial-mesenchymal transition : matrix metallo-protease - 9
Matrix metallo-protease - 9 will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Markers of epithelial-mesenchymal transition : transcription factors
Transcription factors SNAI2 (SLUG), SNAI1 (SNAIL) and zinc-finger E-box binding homeobox (ZEB-1) will be measured
Measured: Day 0 (on the day of inclusion)
Markers of epithelial-mesenchymal transition : transcription factors
Transcription factors SNAI2 (SLUG), SNAI1 (SNAIL) and zinc-finger E-box binding homeobox (ZEB-1) will be measured
Measured: 25 minutes before embolization
Markers of epithelial-mesenchymal transition : transcription factors
Transcription factors SNAI2 (SLUG), SNAIL (SNAI1) and zinc-finger E-box binding homeobox (ZEB-1) will be measured
Measured: 60 minutes after embolization
Markers of epithelial-mesenchymal transition : transcription factors
Transcription factors SNAI2 (SLUG), SNAIL (SNAI1) and zinc-finger E-box binding homeobox (ZEB-1) will be measured
Measured: Week 3 to 4 after patient induction just before rectal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start2 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, RectalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot exploratory descriptive prospective bicentric study to evaluate the safety and efficacy of an innovative procedure: inferior mesenteric artery embolization prior to rectal cancer surgery involving 2 groups: one with standard treatment and the other with inferior mesenteric artery embolization.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236633
- Sponsor's protocol ID
- NIMAO/2022-1/MB-01
- Acronym
- AMIREMBOL_2
- Status last verified
- Nov 2025
- First submitted
- 24 Jan 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Ischemic Preconditioning by Embolization of the Inferior Mesenteric Artery in Oncologic Surgery for Tumors of the Lower and Middle Rectum. Bicentric Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT06236633
- Acronym / sponsor ID
- AMIREMBOL_2 / NIMAO/2022-1/MB-01
- Conditions
- Cancer, Rectal
- Keywords
- Ischemic preconditioning surgery, Cancer, Rectal, Inferior Mesenteric Artery Embolus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will investigate the safety of inferior mesenteric artery embolization prior to rectal surgery, according to IDEAL recommendations (Lancet 2009). It aims to assess the safety of endovascular embolization of the inferior mesenteric artery prior to surgery in patients with rectal tumors, and estimate the potential benefits in terms of time to surgery and the occurrence of post-operative fistulas.The study will also assess the impact of subacute ischemia induced by IMA embolization on colonic vasculature remodeling, colonic ischemic suffering, altered hemostasis and initiation of neo-angiogenesis through blood sampling kinetics.The hypothesis is that ischemic preconditioning by inferior mesenteric artery embolization prior to rectal cancer resection surgery is safe and will result in a decrease in acute relative colon ischemia and a reduction in the rate of fistulas and post-surgical complications. Indeed, we believe that the beneficial effects of the ischemic preconditioning of IMA will be due to better blood perfusion of the colon at 3 weeks, which is apparently linked to remodeling and/or the development of collateral vascularization.
Detailed description
Anastomotic fistulas are the main cause of morbidity and mortality in colorectal surgery. They are responsible for septic complications, leading to increased mortality, local recurrence, repeat surgery and impaired sexual, urinary and digestive function. Fistulas are multifactorial; among the causes, colonic vascularization seems to be a major one. Ligation of the inferior mesenteric artery during rectal surgery has been shown to reduce intraoperative colonic perfusion flow. The left colon is then vascularized only by the colonic border arcade, perfused by the superior mesenteric artery. Ischemic pre-conditioning of the arterial network prior to surgery should ensure better vascularization by developing arterial collaterality and increasing perfusion flow in the colonic border arcade. In view of major advances in interventional radiology, this preconditioning could be achieved by endovascular ligation of the inferior mesenteric artery (IMA), based on the same principle as during surgery: proximal occlusion of the inferior mesenteric artery (IMA), using embolization material (plug or coils), 3 weeks before surgery, to allow the colonic border arcade to develop. We carried out a single-center pilot study (AMIREMBOL 1, NIMAO 2017; Frandon et al. 2022) to assess the feasibility of ischemic preconditioning of the colon for patients with rectal or sigmoid cancer. The study included 10 patients, randomized into two groups: the control group, with preoperative arteriography and standard management and the "embolization" group, with embolization of the IMA three weeks prior to surgery. IMA embolization was successfully performed in all 5 patients in the embolization group, with no major complications. The effect on colonic perfusion, measured by intraoperative Doppler directly on the border arch, with recording of resistance indexes (independent of measurement angle), showed a drop in resistance indexes in the control arm, after ligation of the IMA, which persisted after 5 minutes. In the "Embolization" arm, no drop in this index was reported during surgery, reflecting good development of vascular collaterality and at least relative acute ischemia of the colon after IMA ligation during surgery. Finally, in the "control" group, one anastomotic fistula was reported after surgery and required re-operation. There were no fistulas in the embolization group.
The present study (AMIREMBOL 2) will investigate the safety of IMA embolization prior to rectal surgery, according to IDEAL recommendations (Lancet 2009). Its aim is to assess the safety of endovascular embolization of the IMA prior to surgery in patients with rectal tumors, and to estimate the potential benefits in terms of time to surgery and the occurrence of post-operative fistulas.
The study will also assess the impact of subacute ischemia induced by IMA embolization on colonic vasculature remodeling, colonic ischemic suffering, altered hemostasis and initiation of neo-angiogenesis through blood sampling kinetics.
The hypothesis is that ischemic preconditioning by inferior mesenteric artery (IMA) embolization prior to rectal cancer resection surgery is safe and will result in a decrease in acute relative colon ischemia and a reduction in the rate of fistulas and post-surgical complications. The hypothesis is that the beneficial effects of the ischemic preconditioning of IMA will be due to better blood perfusion of the colon at 3 weeks, which is apparently linked to remodeling and/or the development of collateral vascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot exploratory descriptive prospective bicentric study to evaluate the safety and efficacy of an innovative procedure: inferior mesenteric artery embolization prior to rectal cancer surgery involving 2 groups: one with standard treatment and the other with inferior mesenteric artery embolization.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –In the control group, patients will undergo standard management. |
| Ischemic preconditioning group | Experimental | Procedure: Ischemic preconditioning, Procedure: ArteriogramIn the experimental group, patients will undergo preoperative arteriography and ischemic preconditioning One blood sample will be taken before and two samples taken after embolization of the IMA. These patients will receive a phone call on Day 7 post embolization. A blood sample will also be taken at the time of surgery. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with rectal cancer eligible for surgery with ligation at the origin of the inferior mesenteric artery.
- Patients with free, informed consent.
- Patients affiliated to or benefiting from a health insurance plan.
Key exclusion criteria (14 listed)
- Patients with a history of colon cancer who has undergone colon resection surgery
- Patients with occlusion of the superior mesenteric artery or stenosis of more than 50%, visible on the CT scan performed as part of conventional management during extension workup.
- Patients with occlusion of the IMA on the extension scan.
- Patients with a systemic disorder responsible for haemostasis (haemophilia, Willebrand's disease, thrombocytopenia) and on anticoagulant therapy.
- Patients taking corticosteroids or immunosuppressants leading to an unacceptable surgical risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic preconditioningEmbolization performed via a common right femoral or radial approach, depending on the patient's conformation. Minor complications such as hematoma at the puncture site are rare in less than 1% of cases, and serious complications are exceptional. Proximal occlusion of the inferior mesenteric artery, before its dividing branches, using material adapted to arterial occlusion according to anatomical findings. Proximal occlusion during embolization is evaluated by intravascular injection into the inferior mesenteric artery, and resumption of vascularization of the distal inferior mesenteric artery is controlled by the border arcade injecting into the superior mesenteric artery. In the event of a high-risk anatomical variant, or absence of a border arcade, no embolization will be performed and the patient will be excluded from the study; this will represent no more than 1-2% of patients (surgical series describing 0.83% of ischemia in connection with absence of a border arcade). | Procedure or surgery | Ischemic preconditioning group |
| ArteriogramThe interventional radiologist performs an arteriogram of the inferior and superior mesenteric arteries (IMA and SMA respectively) to check that the SMA is free of anomalies and that the IMA has a proximal trunk long enough for embolization. The radiologist also checks for the presence of a colonic border arcade. If this is absent, embolization will not be performed: the patient will be excluded from the study.This arteriogram is carried out under local anaesthetic specifically for research purposes, as follows: Common right femoral or radial approach and placement of a small introducer. Selective arteriogram of the inferior and superior mesenteric arteries to check perfusion of the border arcade.Arterial closure system or manual compression. Return to surgery or interventional radiology department. Patient discharged the same day after medical assessment (surgeon or interventional radiologist).Telephone check-up on Day1 (standard management) and Day 7 (added as part of the protocol). | Procedure or surgery | Ischemic preconditioning group |
Primary outcome
Safety of endovascular inferior mesenteric artery embolisation prior to surgical resection of the rectum in patients with tumours of the lower and middle rectum.
Time frame: Day 7 post embolization (performed 3 weeks before surgical resection of the rectum)
Percentage of patients with a complication (any grade) within 7 days after embolisation of the inferior mesenteric artery according to the classification of the International Society of Interventional Radiology assessed during the follow-up telephone consultation by the interventional radiologist. Complications will be classified as minor (Grades A and B) or Major (grades C to F). Grade A = No therapy, no consequence Grade B = Nominal therapy, no consequence. Includes overnight admission for observation only Grade C = Requires therapy, minor hospitalization (<48 hours) Grade D = Requires major therapy. Unplanned increase in level of care. Prolonged hospitalization (>48 hours) Grade E = Permanent adverse sequelae Grade F= Death
96 secondary outcomes
Technical success of the embolization procedure
Time frame: Day 0, on the day of embolization
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade I
Time frame: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade II
Time frame: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IIIa
Time frame: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IIIb
Time frame: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IVa
Time frame: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade IVb
Time frame: Post-operative Day 30
Post-surgical complications up to 30 days after surgery. Clavien-Dindo Grade V
Time frame: Post-operative Day 30
Rate of fistulas up to 30 days after surgery
Time frame: Day 0
Rate of fistulas up to 30 days after surgery
Time frame: Post-operative Day 30
Duration of post-surgical hospitalization
Time frame: Up to 30 days after rectal surgery
Degree of difficulty experienced by the visceral surgeon during surgery
Time frame: Week 3 to 4 on the day of rectal surgery
Systemic inflammation markers: Pro-inflammation cytokines
Time frame: Day 0 (on the day of inclusion)
Systemic inflammation markers: Pro-inflammation cytokines
Time frame: 25 minutes before embolization
Systemic inflammation markers: Pro-inflammation cytokines
Time frame: 60 minutes after embolization
Systemic inflammation markers: Pro-inflammation cytokines
Time frame: Week 3 to 4 after patient induction just before rectal surgery
Systemic inflammation markers: Complement protein C3
Time frame: Day 0 (on the day of inclusion)
Systemic inflammation markers: Complement protein C3
Time frame: 25 minutes before embolization
Systemic inflammation markers: Complement protein C3
Time frame: 60 minutes after embolization
Systemic inflammation markers: Complement protein C3
Time frame: Week 3 to 4 after patient induction just before rectal surgery
Anti-inflammation markers:
Time frame: Day 0 (on the day of inclusion)
Anti-inflammation markers:
Time frame: 25 minutes before embolization
Anti-inflammation markers:
Time frame: 60 minutes after embolization
Anti-inflammation markers:
Time frame: Week 3 to 4 after patient induction just before rectal surgery
Hemostasis markers : Von Willebrand factor
Time frame: Day 0 (on the day of inclusion)
Hemostasis markers : Von Willebrand factor
Time frame: 25 minutes before embolization
Hemostasis markers : Von Willebrand factor
Time frame: 60 minutes after embolization
Hemostasis markers : Von Willebrand factor
Time frame: Week 3 to 4 after patient induction just before rectal surgery
Hemostasis markers : coagulation factor V
Time frame: Day 0 (on the day of inclusion)
Hemostasis markers : coagulation factor V
Time frame: 25 minutes before embolization
Hemostasis markers : coagulation factor V
Time frame: 60 minutes after embolization
Hemostasis markers : coagulation factor V
Time frame: Week 3 to 4 after patient induction just before rectal surgery
Hemostasis markers : D-dimers
Time frame: Day 0 (on the day of inclusion)
Hemostasis markers : D-dimers
Time frame: 25 minutes before embolization
Hemostasis markers : D-dimers
Time frame: 60 minutes after embolization
Hemostasis markers : D-dimers
Time frame: Week 3 to 4 after patient induction just before rectal surgery
Hemostasis markers : platelet-activating factor (PAF)
Time frame: Day 0 (on the day of inclusion)
Hemostasis markers : platelet-activating factor (PAF)
Time frame: 25 minutes before embolization
Hemostasis markers : platelet-activating factor (PAF)
Time frame: 60 minutes after embolization
Hemostasis markers : platelet-activating factor (PAF)
Time frame: Week 3 to 4 after patient induction just before rectal surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic preconditioning and Arteriogram in people with Cancer, Rectal, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin BERTRAND, Professor (+336.43.50.35.22, martin.bertrand@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of endovascular inferior mesenteric artery embolisation prior to surgical resection of the rectum in patients with tumours of the lower and middle rectum. (time frame: Day 7 post embolization (performed 3 weeks before surgical resection of the rectum)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.