Crohn's DiseaseRIC-1NCT06299631
Endoscopic Relapse Risks Evaluation After Ileocolic Resection for Crohn's Disease
An observational study of Crohn's Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Aim of the study: To evaluate risk factors of endoscopic relapse after ileocolic resection in a cohort of Crohn's disease patients treated with anti-TNF agents. Methods: From 2014 to 2022, all consecutive patients who underwent ileocolic resection for Crohn's disease treated with anti-TNF agents in two referral… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Ileocolic resection
- Type of treatment
- Surgery or procedure
- How many people
- 133 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- Adult, Older adult
Study population: All patients with Crohn's disease treated with TNF inhibitors who underwent ileocolic resection between 2014 and 2023 in the Digestive Surgery (A), Oncology and Minimally Invasive Department (Pr FABRE) of the Montpellier University Hospital and the Digestive Surgery and Cancer Department (Pr PRUDHOMME) of the Nimes University Hospital
Who may be able to join
- Patients with histologically proven Crohn's disease
- On anti-TNF alpha: infliximab, adalimumab (ECCO 2014 recommendation)
- > 18 years old patients
- All patients who have undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat procedure)
Who cannot join
- Minor patients under 18 years of age
- Endoscopic follow-up not possible
- Pregnant women
- Medical treatment other than anti-TNF alpha
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Relapse Risk Factors After Ileocolic Resection on Crohn's Disease Patients in the Biologic Era
Aim of the study:
To evaluate risk factors of endoscopic relapse after ileocolic resection in a cohort of Crohn's disease patients treated with anti-TNF agents.
Methods:
From 2014 to 2022, all consecutive patients who underwent ileocolic resection for Crohn's disease treated with anti-TNF agents in two referral tertiary center were prospectively collected.
Considering exclusion criteria, data from 114 patients were analyzed. The cohort was separated into 2 groups according to study period.
Short and long-term outcomes were compared between the two groups.
Primary outcome:
Endoscopic recurrence (defined as > i2 lesions according to Rutgeerts classification) 6 months after surgery
Read the detailed description
Crohn's disease is a chronic inflammatory bowel disease whose preferential location is the ileo-colon, for which surgical management is necessary in 60% of patients.
The most common surgical procedure is ileo-caecal resection for symptomatic last ileal loop stenosis resistant to a well conducted medical treatment.
The conventional surgical technique aims to preserve the length of the digestive tract as much as possible. From a technical point of view, the resection passes as close as possible to the small intestine, leaving the vessels within the mesentery in place.
Despite the improvement of therapeutics (over the last decade, 80% of patients present an endoscopic recurrence at 1 year after surgery. Endoscopic recurrence is defined as the apparition of new typical mucosal lesions based on the Rutgeerts classification.
According to the last ECCO guidelines, biologic agents (TNF-inhibitors, ustekinumab and vedolizumab) are used as maintenance treatment in moderate-to-severe Crohn's disease patients:
- who achieved remission with anti-TNF agents -> maintenance treatment using the same treatment.
- who have achieved long-term remission with the combination of infliximab and immunosuppressants -> monotherapy with infliximab.
- who have achieved long-term remission with the combination of adalimumab and immunosuppressants -> monotherapy with adalimumab. The risk factors for postoperative recurrence are now well established and include smoking habit, penetrating or fistulizing phenotype (classified as B3 in the Montréal classification), perineal disease, history of previous bowel resection, extensive small bowel resection (>20 cm).
Recently, the role of the mesentery in Crohn's disease has been deeply investigated. There is a mesenteric nerve dysfunction with inhibition of anti-inflammatory activity, a major angiogenesis, a multiplication of lymphatic vessels with emboli at the origin of lymphatic drainage abnormalities, a mesenteric hypertrophy with multiple small adipocytes secreting adipokines.
These new elements have raised the question of a potential benefit of a combined resection of the mesentery during an ileocecal resection in the treatment of Crohn's disease.
CALVIN J Coffrey et al. carried out a study in 2008 comparing a prospective cohort with ileo-caecal resection including the mesentery (mesentery resection group) to a retrospective cohort with classical ileocecal resections (ICR group). The results were very promising in terms of recurrence requiring surgical management with a re-operation rate at 5 years of 40% in the classical ICR group vs 2.9% in the mesenteric resection group. And shows that significant mesenteric disease is an independent risk factor for recurrence with a HR=4.7 (p<0.007).
Thus, it is necessary to analyse within local patient base: the percentage of endoscopic recurrence at 6 months after surgery in patients treated with anti TNFa as well as the risk factors at the origin of the increase of these recurrences, more particularly the anatomopathological factors which could call into question the surgical practices within the long term a major interest in resection of the mesentery.
Therefore, the investigator carried out a retrospective study in two referral tertiary center, Montpellier University Hospital and Nîmes University Hospital. The investigator prospectively collected data from 2014 to 2022 from Crohn's disease patients treated with TNF inhibitors who have undergone ileocolic resection, to determine the percentage of endoscopic recurrence at 6 months and its risk factors.
- Conditions
- Crohn's Disease
- Being tested
- Ileocolic resection
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ileocolic resectionProcedure or surgery
Ileocolic resection by open or laparoscopic approach
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease patients undergoing ICR | Crohn's disease patients undergoing ICR treated with TNF inhibitors Receives: Procedure: Ileocolic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic recurrence rate
Defined as the presenc of new mucosal lesions classified >i2 according to Rutgeerts classification.
Measured: 6 months after surgery
Secondary outcomes (8)
Resection margins
Pathological examination of resection margins
Measured: 90 days after surgery
Length of resected specimen
Pathological examination and measure of the lenght of ileon and colon resection
Measured: 90 days after surgery
Duration of surgery
Operative time
Measured: 90 days after surgery
Intra-operative blood loss
Intra-operative blood losss
Measured: 90 days after surgery
Postoperative morbidity rate
Postoperative morbidity according to Clavien Dindo
Measured: 90 days after surgery
Mortality rate
Death occuring within 90 days after surgery
Measured: 90 days after surgery
Myenteric plexitis
Myenteric plexitis defined as the presence of > 3 inflammatory cells in myenteric plexuses of the proximal resection margin
Measured: 90 days after surgery
Number of inflammatory cells in myenteric plexuses
Number of inflammatory cells in myenteric plexuses of inflammatory cells in myenteric plexuses
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startJan 2015
- Primary completionJun 2023
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Carémeau University Hospital, Nîmes
- Responsible party
- Sponsor
- Investigators
- Thomas BARDOL, MD, MSc, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299631
- Sponsor's protocol ID
- RECHMPL23_0187
- Acronym
- RIC-1
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Relapse Risk Factors After Ileocolic Resection on Crohn's Disease Patients in the Biologic Era
- ClinicalTrials.gov ID
- NCT06299631
- Acronym / sponsor ID
- RIC-1 / RECHMPL23_0187
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Carémeau University Hospital, Nîmes
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2023 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 8 Mar 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.
Aim of the study:
To evaluate risk factors of endoscopic relapse after ileocolic resection in a cohort of Crohn's disease patients treated with anti-TNF agents.
Methods:
From 2014 to 2022, all consecutive patients who underwent ileocolic resection for Crohn's disease treated with anti-TNF agents in two referral tertiary center were prospectively collected.
Considering exclusion criteria, data from 114 patients were analyzed. The cohort was separated into 2 groups according to study period.
Short and long-term outcomes were compared between the two groups.
Primary outcome:
Endoscopic recurrence (defined as > i2 lesions according to Rutgeerts classification) 6 months after surgery
Detailed description
Crohn's disease is a chronic inflammatory bowel disease whose preferential location is the ileo-colon, for which surgical management is necessary in 60% of patients.
The most common surgical procedure is ileo-caecal resection for symptomatic last ileal loop stenosis resistant to a well conducted medical treatment.
The conventional surgical technique aims to preserve the length of the digestive tract as much as possible. From a technical point of view, the resection passes as close as possible to the small intestine, leaving the vessels within the mesentery in place.
Despite the improvement of therapeutics (over the last decade, 80% of patients present an endoscopic recurrence at 1 year after surgery. Endoscopic recurrence is defined as the apparition of new typical mucosal lesions based on the Rutgeerts classification.
According to the last ECCO guidelines, biologic agents (TNF-inhibitors, ustekinumab and vedolizumab) are used as maintenance treatment in moderate-to-severe Crohn's disease patients:
- who achieved remission with anti-TNF agents -> maintenance treatment using the same treatment.
- who have achieved long-term remission with the combination of infliximab and immunosuppressants -> monotherapy with infliximab.
- who have achieved long-term remission with the combination of adalimumab and immunosuppressants -> monotherapy with adalimumab. The risk factors for postoperative recurrence are now well established and include smoking habit, penetrating or fistulizing phenotype (classified as B3 in the Montréal classification), perineal disease, history of previous bowel resection, extensive small bowel resection (>20 cm).
Recently, the role of the mesentery in Crohn's disease has been deeply investigated. There is a mesenteric nerve dysfunction with inhibition of anti-inflammatory activity, a major angiogenesis, a multiplication of lymphatic vessels with emboli at the origin of lymphatic drainage abnormalities, a mesenteric hypertrophy with multiple small adipocytes secreting adipokines.
These new elements have raised the question of a potential benefit of a combined resection of the mesentery during an ileocecal resection in the treatment of Crohn's disease.
CALVIN J Coffrey et al. carried out a study in 2008 comparing a prospective cohort with ileo-caecal resection including the mesentery (mesentery resection group) to a retrospective cohort with classical ileocecal resections (ICR group). The results were very promising in terms of recurrence requiring surgical management with a re-operation rate at 5 years of 40% in the classical ICR group vs 2.9% in the mesenteric resection group. And shows that significant mesenteric disease is an independent risk factor for recurrence with a HR=4.7 (p<0.007).
Thus, it is necessary to analyse within local patient base: the percentage of endoscopic recurrence at 6 months after surgery in patients treated with anti TNFa as well as the risk factors at the origin of the increase of these recurrences, more particularly the anatomopathological factors which could call into question the surgical practices within the long term a major interest in resection of the mesentery.
Therefore, the investigator carried out a retrospective study in two referral tertiary center, Montpellier University Hospital and Nîmes University Hospital. The investigator prospectively collected data from 2014 to 2022 from Crohn's disease patients treated with TNF inhibitors who have undergone ileocolic resection, to determine the percentage of endoscopic recurrence at 6 months and its risk factors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease patients undergoing ICR | – | Procedure: Ileocolic resectionCrohn's disease patients undergoing ICR treated with TNF inhibitors |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with Crohn's disease treated with TNF inhibitors who underwent ileocolic resection between 2014 and 2023 in the Digestive Surgery (A), Oncology and Minimally Invasive Department (Pr FABRE) of the Montpellier University Hospital and the Digestive Surgery and Cancer Department (Pr PRUDHOMME) of the Nimes University Hospital
Key inclusion criteria (4 listed)
- Patients with histologically proven Crohn's disease
- On anti-TNF alpha: infliximab, adalimumab (ECCO 2014 recommendation)
- > 18 years old patients
- All patients who have undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat procedure)
Key exclusion criteria (4 listed)
- Minor patients under 18 years of age
- Endoscopic follow-up not possible
- Pregnant women
- Medical treatment other than anti-TNF alpha
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 |
|---|---|---|
| Ileocolic resectionIleocolic resection by open or laparoscopic approach | Procedure or surgery | Crohn's disease patients undergoing ICR |
Primary outcome
Endoscopic recurrence rate
Time frame: 6 months after surgery
Defined as the presenc of new mucosal lesions classified >i2 according to Rutgeerts classification.
8 secondary outcomes
Resection margins
Time frame: 90 days after surgery
Length of resected specimen
Time frame: 90 days after surgery
Duration of surgery
Time frame: 90 days after surgery
Intra-operative blood loss
Time frame: 90 days after surgery
Postoperative morbidity rate
Time frame: 90 days after surgery
Mortality rate
Time frame: 90 days after surgery
Myenteric plexitis
Time frame: 90 days after surgery
Number of inflammatory cells in myenteric plexuses
Time frame: 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thomas BARDOL, MD, MSc principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by University Hospital, Montpellier at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic recurrence rate (time frame: 6 months after surgery). 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 8 Mar 2024.