Crohn DiseaseNCT06550843
Mesentery Guide Identify Microscopic Clean Resection and Reduces Crohn's Endoscopic Recurrence
An observational study of Crohn Disease and Recurrence, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
Microscopic clean margin is associated with reduced endoscopic recurrence after bowel resection for ileocolic Crohn's disease (CD). We aimed to investigate whether the extent of creeping fat could help indicate microscopic inflammation beyond naked eye assessment of the bowel wall and reduce endoscopic recurrence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Recurrence
- What is being tested?
- mesentery-guided division
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2013to 1 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For the pathological study, we prospectively enrolled consecutive CD patients who underwent ileocolic resections between January 2021 and August 2021 at the 6th Hospital of Sun Yat-Sen University (SYSU6H) For the surgical study, we retrospectively enrolled consecutive CD patients that underwent ileocolic resection from January 2013 to July 2020
Who may be able to join
- Localized ileocolic CD
Who cannot join
- Patients with a stoma,residuallesion ,history of bowel resection,or post-operative abdominalinfection were excluded
About this study
Official title: Mesentery Abnormality to Identify Microscopic Clean Resection and Reduce Postoperative Endoscopic Recurrence in Ileocolic Crohn's Disease
Microscopic clean margin is associated with reduced endoscopic recurrence after bowel resection for ileocolic Crohn's disease (CD). We aimed to investigate whether the extent of creeping fat could help indicate microscopic inflammation beyond naked eye assessment of the bowel wall and reduce endoscopic recurrence after ileocolic resection.
Read the detailed description
Despite proactive prophylactic treatment administered after surgery for Crohn's disease (CD) patients, early postoperative endoscopic recurrence (EPER) still occurs in 50-80% of patients within six months, increasing the risk of long-term clinical and surgical recurrence. Risk factors for EPER have already been identified, including active smoking, disease behavior, younger age, concomitant perianal disease, prior intestinal resections, and microscopic resection margin positivity. Recently, the influence of microscopic inflammation at the resection margin on EPER has been highlighted by various studies and meta-analysis.
From a surgical perspective, it has become common practice to conservatively resect 2cm width from the gross lesion to lower re-operation risks, while the optimal strategy to attain the microscopic clean margin and minimize EPER remain unclear, considering the limited accuracy of frozen-section examinations. More importantly, the diseased mucosa proximal to the ileal lesion can be healed by preoperative optimization, potentially concealing deeper lesions at the muscularis propria and serosal levels from visual assessment during surgery. Therefore, identifying a macroscopic marker that highly correlates with microscopic inflammation is essential to help locate the clean division.
As a hallmark of CD, the hyperplasia of mesenteric adipose tissue (MAT) or "Creeping fat," was found directly triggered by transmural inflammation and bacterial translocation from CD affected lumen11. Correspondingly, creeping fat has been found to correlate with macroscopic mucosal abnormalities observed after opening the bowel12. However, its relationship with microscopic inflammation, as well as its potential role in determining the division position to achieve better EPER outcomes, remains to be clarified.
- Conditions
- Crohn Disease, Recurrence
- Being tested
- mesentery-guided division
- Keywords
- Mesentery Guide, Microscopic Clean Resection, Endoscopic Recurrence
- Medical subject headings
- Crohn Disease, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesentery-guided divisionProcedure or surgery
In the Mes-G group, all surgeries were performed by one surgeon team (J.K.) from January 2013 using the following strategy for the proximal division site: the diseased bowel and para-intestinal mesentery were carefully compared by palpation and translucent observation through a shadowless lamp. The comparison was conducted from the diseased bowel towards the normal-appearing region upstream, to identify a point where the hypertrophied mesentery transitioned into normal thickness and softness and became translucent as observed through the shadowless lamp.
| Study group | Role | What they receive |
|---|---|---|
| conventional group | In the conventional group, the cutting line was approximately 2cm proximal to the macroscopic lesion where the mucosa and intestinal wall appeared macroscopically normal, regardless of the adjacent mesentery. | |
| mesentery-guided group (Mes-G) | In the Mes-G group, all surgeries were performed by one surgeon team (J.K.) from January 2013 using the following strategy for the proximal division site: the diseased bowel and para-intestinal mesentery were carefully compared by palpation and translucent observation through a shadowless lamp. The comparison was conducted from the diseased bowel towards the normal-appearing region upstream, to identify a point where the hypertrophied mesentery transitioned into normal thickness and softness and became translucent as observed through the shadowless lamp. Receives: Procedure: mesentery-guided division |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's Endoscopic Recurrence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Feb 2013
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Ke, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550843
- Sponsor's protocol ID
- Sixth Affiliated Hospital 001
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hammoudi N, Cazals-Hatem D, Auzolle C, Gardair C, Ngollo M, Bottois H, Nancey S, Pariente B, Buisson A, Treton X, Fumery M, Bezault M, Seksik P, Le Bourhis L; REMIND Study Group Investigators; Flejou JF, Allez M. Association Between Microscopic Lesions at Ileal Resection Margin and Recurrence After Surgery in Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Jan;18(1):141-149.e2. doi: 10.1016/j.cgh.2019.04.045. Epub 2019 Apr 28.
PubMed 31042575Tandon P, Malhi G, Abdali D, Pogue E, Marshall JK, de Buck van Overstraeten A, Riddell R, Narula N. Active Margins, Plexitis, and Granulomas Increase Postoperative Crohn's Recurrence: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2021 Mar;19(3):451-462. doi: 10.1016/j.cgh.2020.08.014. Epub 2020 Aug 12.
PubMed 32801016Poredska K, Kunovsky L, Marek F, Kala Z, Prochazka V, Dolina J, Zboril V, Kovalcikova P, Pavlik T, Jabandziev P, Pavlovsky Z, Vlazny J, Mitas L. The Influence of Microscopic Inflammation at Resection Margins on Early Postoperative Endoscopic Recurrence After Ileocaecal Resection for Crohn's Disease. J Crohns Colitis. 2020 Mar 13;14(3):361-368. doi: 10.1093/ecco-jcc/jjz153.
PubMed 31501878Fazio VW, Marchetti F, Church M, Goldblum JR, Lavery C, Hull TL, Milsom JW, Strong SA, Oakley JR, Secic M. Effect of resection margins on the recurrence of Crohn's disease in the small bowel. A randomized controlled trial. Ann Surg. 1996 Oct;224(4):563-71; discussion 571-3. doi: 10.1097/00000658-199610000-00014.
PubMed 8857860Muller JM, Keller HW, Erasmi H, Pichlmaier H. Total parenteral nutrition as the sole therapy in Crohn's disease--a prospective study. Br J Surg. 1983 Jan;70(1):40-3. doi: 10.1002/bjs.1800700116.
PubMed 6402050Regueiro M, Velayos F, Greer JB, Bougatsos C, Chou R, Sultan S, Singh S. American Gastroenterological Association Institute Technical Review on the Management of Crohn's Disease After Surgical Resection. Gastroenterology. 2017 Jan;152(1):277-295.e3. doi: 10.1053/j.gastro.2016.10.039. Epub 2016 Nov 10. No abstract available.
PubMed 27840073Panes J, Rimola J. Perianal fistulizing Crohn's disease: pathogenesis, diagnosis and therapy. Nat Rev Gastroenterol Hepatol. 2017 Nov;14(11):652-664. doi: 10.1038/nrgastro.2017.104. Epub 2017 Aug 9.
PubMed 28790453
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesentery Abnormality to Identify Microscopic Clean Resection and Reduce Postoperative Endoscopic Recurrence in Ileocolic Crohn's Disease
- ClinicalTrials.gov ID
- NCT06550843
- Acronym / sponsor ID
- Sixth Affiliated Hospital 001
- Conditions
- Crohn Disease, Recurrence
- Keywords
- Mesentery Guide, Microscopic Clean Resection, Endoscopic Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 13 Aug 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.
Microscopic clean margin is associated with reduced endoscopic recurrence after bowel resection for ileocolic Crohn's disease (CD). We aimed to investigate whether the extent of creeping fat could help indicate microscopic inflammation beyond naked eye assessment of the bowel wall and reduce endoscopic recurrence after ileocolic resection.
Detailed description
Despite proactive prophylactic treatment administered after surgery for Crohn's disease (CD) patients, early postoperative endoscopic recurrence (EPER) still occurs in 50-80% of patients within six months, increasing the risk of long-term clinical and surgical recurrence. Risk factors for EPER have already been identified, including active smoking, disease behavior, younger age, concomitant perianal disease, prior intestinal resections, and microscopic resection margin positivity. Recently, the influence of microscopic inflammation at the resection margin on EPER has been highlighted by various studies and meta-analysis.
From a surgical perspective, it has become common practice to conservatively resect 2cm width from the gross lesion to lower re-operation risks, while the optimal strategy to attain the microscopic clean margin and minimize EPER remain unclear, considering the limited accuracy of frozen-section examinations. More importantly, the diseased mucosa proximal to the ileal lesion can be healed by preoperative optimization, potentially concealing deeper lesions at the muscularis propria and serosal levels from visual assessment during surgery. Therefore, identifying a macroscopic marker that highly correlates with microscopic inflammation is essential to help locate the clean division.
As a hallmark of CD, the hyperplasia of mesenteric adipose tissue (MAT) or "Creeping fat," was found directly triggered by transmural inflammation and bacterial translocation from CD affected lumen11. Correspondingly, creeping fat has been found to correlate with macroscopic mucosal abnormalities observed after opening the bowel12. However, its relationship with microscopic inflammation, as well as its potential role in determining the division position to achieve better EPER outcomes, remains to be clarified.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | – | –In the conventional group, the cutting line was approximately 2cm proximal to the macroscopic lesion where the mucosa and intestinal wall appeared macroscopically normal, regardless of the adjacent mesentery. |
| mesentery-guided group (Mes-G) | – | Procedure: mesentery-guided divisionIn the Mes-G group, all surgeries were performed by one surgeon team (J.K.) from January 2013 using the following strategy for the proximal division site: the diseased bowel and para-intestinal mesentery were carefully compared by palpation and translucent observation through a shadowless lamp. The comparison was conducted from the diseased bowel towards the normal-appearing region upstream, to identify a point where the hypertrophied mesentery transitioned into normal thickness and softness and became translucent as observed through the shadowless lamp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For the pathological study, we prospectively enrolled consecutive CD patients who underwent ileocolic resections between January 2021 and August 2021 at the 6th Hospital of Sun Yat-Sen University (SYSU6H) For the surgical study, we retrospectively enrolled consecutive CD patients that underwent ileocolic resection from January 2013 to July 2020
Key inclusion criteria (1 listed)
- Localized ileocolic CD
Key exclusion criteria (1 listed)
- Patients with a stoma,residuallesion ,history of bowel resection,or post-operative abdominalinfection were excluded
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 |
|---|---|---|
| mesentery-guided divisionIn the Mes-G group, all surgeries were performed by one surgeon team (J.K.) from January 2013 using the following strategy for the proximal division site: the diseased bowel and para-intestinal mesentery were carefully compared by palpation and translucent observation through a shadowless lamp. The comparison was conducted from the diseased bowel towards the normal-appearing region upstream, to identify a point where the hypertrophied mesentery transitioned into normal thickness and softness and became translucent as observed through the shadowless lamp. | Procedure or surgery | mesentery-guided group (Mes-G) |
Primary outcome
Crohn's Endoscopic Recurrence
Time frame: 12 months
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 13 Aug 2024.
- Background: PubMed 31042575Hammoudi N, Cazals-Hatem D, Auzolle C, Gardair C, Ngollo M, Bottois H, Nancey S, Pariente B, Buisson A, Treton X, Fumery M, Bezault M, Seksik P, Le Bourhis L; REMIND Study Group Investigators; Flejou JF, Allez M. Association Between Microscopic Lesions at Ileal Resection Margin and Recurrence After Surgery in Patients With Crohn's Disease. Clin Gastroenterol Hepatol. 2020 Jan;18(1):141-149.e2. doi: 10.1016/j.cgh.2019.04.045. Epub 2019 Apr 28.
- Background: PubMed 32801016Tandon P, Malhi G, Abdali D, Pogue E, Marshall JK, de Buck van Overstraeten A, Riddell R, Narula N. Active Margins, Plexitis, and Granulomas Increase Postoperative Crohn's Recurrence: Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2021 Mar;19(3):451-462. doi: 10.1016/j.cgh.2020.08.014. Epub 2020 Aug 12.
- Background: PubMed 31501878Poredska K, Kunovsky L, Marek F, Kala Z, Prochazka V, Dolina J, Zboril V, Kovalcikova P, Pavlik T, Jabandziev P, Pavlovsky Z, Vlazny J, Mitas L. The Influence of Microscopic Inflammation at Resection Margins on Early Postoperative Endoscopic Recurrence After Ileocaecal Resection for Crohn's Disease. J Crohns Colitis. 2020 Mar 13;14(3):361-368. doi: 10.1093/ecco-jcc/jjz153.
- Background: PubMed 8857860Fazio VW, Marchetti F, Church M, Goldblum JR, Lavery C, Hull TL, Milsom JW, Strong SA, Oakley JR, Secic M. Effect of resection margins on the recurrence of Crohn's disease in the small bowel. A randomized controlled trial. Ann Surg. 1996 Oct;224(4):563-71; discussion 571-3. doi: 10.1097/00000658-199610000-00014.
- Results publication: PubMed 6402050Muller JM, Keller HW, Erasmi H, Pichlmaier H. Total parenteral nutrition as the sole therapy in Crohn's disease--a prospective study. Br J Surg. 1983 Jan;70(1):40-3. doi: 10.1002/bjs.1800700116.
- Results publication: PubMed 27840073Regueiro M, Velayos F, Greer JB, Bougatsos C, Chou R, Sultan S, Singh S. American Gastroenterological Association Institute Technical Review on the Management of Crohn's Disease After Surgical Resection. Gastroenterology. 2017 Jan;152(1):277-295.e3. doi: 10.1053/j.gastro.2016.10.039. Epub 2016 Nov 10. No abstract available.
- Results publication: PubMed 28790453Panes J, Rimola J. Perianal fistulizing Crohn's disease: pathogenesis, diagnosis and therapy. Nat Rev Gastroenterol Hepatol. 2017 Nov;14(11):652-664. doi: 10.1038/nrgastro.2017.104. Epub 2017 Aug 9.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Recurrence, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 1 inclusion and 1 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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Crohn's Endoscopic Recurrence (time frame: 12 months). 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 NCT06550843, which also lists 7 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 13 Aug 2024.