Crohn's DiseaseSPICYNCT04538638
Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease
A study testing Mesenteric sparing ileocolic resection and Central mesenterectomy ileocolic resection in people with Crohn's Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The aim of this multicenter randomised controlled trial is to analyse the six month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for CD. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Mesenteric sparing ileocolic resection and Central mesenterectomy ileocolic resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2020to 27 Nov 2023
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Ileocolic disease with an indication for ileocecal resection
- Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
- All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
- Ability to comply with protocol.
- Competent and able to provide written informed consent.
- Patient must have been discussed in the local MDT
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Inability to give informed consent.
- patients less than 16 years of age.
- Patients undergoing repeated ileocolic resection.
- Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
- History of cancer < 5 years which might influence patients prognosis
Show all 9Show fewer
- Emergent operation.
- Pregnant or breast feeding.
- Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC - Location AMC
Amsterdam, Meibergdreef 9, 1105 AZ
About this study
The aim of this multicenter randomised controlled trial is to analyse the six month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for CD.
Read the detailed description
There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery rather than just of the bowel alone. A more extensive central mesenterectomy (up to the level of the ileocolic artery), in order to remove an increased volume of affected mesentery to prevent postoperative CD, has been suggested to lead to beneficial results. It is hypothesised that patients who undergo a central mesenterectomy during an ileocolic resection compared to a mesenteric sparing ileocolic resection will have decreased recurrence rates.
- Conditions
- Crohn's Disease
- Being tested
- Mesenteric sparing ileocolic resection, Central mesenterectomy ileocolic resection
- Keywords
- Crohn's Disease, Ileocolic, Mesenteric Sparing, Extended Mesenterectomy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenteric sparing ileocolic resectionProcedure or surgery
Mesentery left in situ
Central mesenterectomy ileocolic resectionProcedure or surgery
Mesentery is taken up to the level of the ileocolic trunk
| Study group | Role | What they receive |
|---|---|---|
| Mesenteric Sparing ileocolic resection | Active comparator | Standard procedure for CD, ileocolic resection without removal of the mesentery. Receives: Procedure: Mesenteric sparing ileocolic resection |
| Central mesenterectomy ileocolic resection | Active comparator | Experimental procedure for CD: ileocolic resection in which the mesentery is taken up to the level of the ileocolic trunc. Receives: Procedure: Central mesenterectomy ileocolic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection
Measured: 6 months after surgery
Secondary outcomes (4)
Postoperative morbidity
Number of patients with Postoperative morbidity
Measured: 30 days after surgery
Clinical recurrence rate following ileocolic resection
Number of patients with Clinical recurrence rate following ileocolic resection
Measured: 1 year after surgery
The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence
.The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence
Measured: 1 year after surgery
The 5 year reoperation rate for recurrence of disease at the anastomotic site.
The 5 year reoperation rate for recurrence of disease at the anastomotic site.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Mar 2020
- Primary completion1 May 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Patients with Crohn's disease will be randomised in a 1:1 ratio for mesenteric sparing versus central mesenterectomy when performing an ileocolic resection for Crohn's disease
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Willem A. Bemelman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Christianne J Buskens, Principal investigator, Amsterdam UMC, location AMCWillem A Bemelman, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538638
- Sponsor's protocol ID
- NL61632.018.18
- Acronym
- SPICY
- Status last verified
- Dec 2023
- First submitted
- 31 Aug 2020
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van der Does de Willebois EML; SPICY study group. Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial. BJS Open. 2022 Jan 6;6(1):zrab136. doi: 10.1093/bjsopen/zrab136.
PubMed 35171266van der Does de Willebois EML, Bellato V, Duijvestein M, van der Bilt JDW, van Dongen K, Spinelli A, D'Haens GR, Mundt MW, Furfaro F, Danese S, Vignali A, Bemelman WA, Buskens CJ; SPICY collaborator group. Effect of mesenteric sparing or extended resection in primary ileocolic resection for Crohn's disease on postoperative endoscopic recurrence (SPICY): an international, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Sep;9(9):793-801. doi: 10.1016/S2468-1253(24)00097-9. Epub 2024 Jul 15.
PubMed 39025100
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease
- ClinicalTrials.gov ID
- NCT04538638
- Acronym / sponsor ID
- SPICY / NL61632.018.18
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Ileocolic, Mesenteric Sparing, Extended Mesenterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 4 Sep 2020 (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 aim of this multicenter randomised controlled trial is to analyse the six month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for CD.
Detailed description
There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery rather than just of the bowel alone. A more extensive central mesenterectomy (up to the level of the ileocolic artery), in order to remove an increased volume of affected mesentery to prevent postoperative CD, has been suggested to lead to beneficial results. It is hypothesised that patients who undergo a central mesenterectomy during an ileocolic resection compared to a mesenteric sparing ileocolic resection will have decreased recurrence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients with Crohn's disease will be randomised in a 1:1 ratio for mesenteric sparing versus central mesenterectomy when performing an ileocolic resection for Crohn's disease
| Arm | Type | Receives |
|---|---|---|
| Mesenteric Sparing ileocolic resection | Active comparator | Procedure: Mesenteric sparing ileocolic resectionStandard procedure for CD, ileocolic resection without removal of the mesentery. |
| Central mesenterectomy ileocolic resection | Active comparator | Procedure: Central mesenterectomy ileocolic resectionExperimental procedure for CD: ileocolic resection in which the mesentery is taken up to the level of the ileocolic trunc. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Ileocolic disease with an indication for ileocecal resection
- Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
- All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease.
- Ability to comply with protocol.
Key exclusion criteria (9 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Inability to give informed consent.
- patients less than 16 years of age.
- Patients undergoing repeated ileocolic resection.
- Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
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 |
|---|---|---|
| Mesenteric sparing ileocolic resectionMesentery left in situ | Procedure or surgery | Mesenteric Sparing ileocolic resection |
| Central mesenterectomy ileocolic resectionMesentery is taken up to the level of the ileocolic trunk | Procedure or surgery | Central mesenterectomy ileocolic resection |
Primary outcome
The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection
Time frame: 6 months after surgery
4 secondary outcomes
Postoperative morbidity
Time frame: 30 days after surgery
Clinical recurrence rate following ileocolic resection
Time frame: 1 year after surgery
The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence
Time frame: 1 year after surgery
The 5 year reoperation rate for recurrence of disease at the anastomotic site.
Time frame: 5 years
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 26 Dec 2023.
- Background: PubMed 35171266van der Does de Willebois EML; SPICY study group. Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial. BJS Open. 2022 Jan 6;6(1):zrab136. doi: 10.1093/bjsopen/zrab136.
- Derived from this study: PubMed 39025100van der Does de Willebois EML, Bellato V, Duijvestein M, van der Bilt JDW, van Dongen K, Spinelli A, D'Haens GR, Mundt MW, Furfaro F, Danese S, Vignali A, Bemelman WA, Buskens CJ; SPICY collaborator group. Effect of mesenteric sparing or extended resection in primary ileocolic resection for Crohn's disease on postoperative endoscopic recurrence (SPICY): an international, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Sep;9(9):793-801. doi: 10.1016/S2468-1253(24)00097-9. Epub 2024 Jul 15.
- Individual participant dataSharing planned: No
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Christianne J Buskens principal investigator
Amsterdam UMC, location AMC
Willem A Bemelman principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesenteric sparing ileocolic resection and Central mesenterectomy ileocolic resection in people with Crohn's Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 7 inclusion and 9 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 26 Dec 2023. 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 Netherlands. 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?
The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection (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?
On the ClinicalTrials.gov record for NCT04538638, which also lists 2 linked publications.
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 26 Dec 2023.