Mesenteric Surgical Margin for Crohn's Disease Endoscopic Recurrence
NCT ID: NCT06241170
Last Updated: 2025-07-15
Study Results
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Basic Information
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RECRUITING
NA
172 participants
INTERVENTIONAL
2025-07-01
2031-12-31
Brief Summary
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From a surgical perspective, there have been limited breakthroughs in improving surgical techniques to reduce the postoperative endoscopic recurrence rate in CD. Recent research indicates that microscopic inflammation at the cut edge of the CD bowel segment is a significant risk factor for postoperative endoscopic recurrence. Mesenteric wrapping is a unique clinical pathological feature of CD. Our retrospective data suggest a clear linear correlation between the degree of mesenteric wrapping and microscopic inflammation in the corresponding bowel segment. Surgical margins determined by mesenteric guidance significantly reduce the postoperative endoscopic recurrence rate and clinical relapse rate compared to the traditional 2 cm margin. However, there is currently no prospective study comparing the efficacy of these two surgical approaches.To address this, investigators plan to conduct a multicenter randomized controlled trial. This trial will focus on patients with ileocolonic CD who have undergone primary anastomosis without residual disease. investigators aim to compare the postoperative endoscopic recurrence rates between mesenteric-guided margins and the traditional 2 cm margins. Our goal is to determine whether mesenteric-guided margins can reduce the postoperative endoscopic recurrence rate and to conduct relevant mechanistic research. Ultimately, this research may lead to the development of a novel surgical approach for CD based on the findings of this study.
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Detailed Description
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Therefore, reducing early endoscopic anastomotic recurrence post-surgery has been a focus of CD research. The quality of surgical procedures significantly impacts this outcome. Previous research has identified risk factors for post-surgical recurrence, including smoking history, previous bowel resections, penetrating disease, extensive involvement, and concomitant perianal disease (6-8). However, these are non-modifiable patient-related factors. Within the scope of what physicians can control, proactive preventive treatment approaches adopted by gastroenterologists have been shown to reduce endoscopic recurrence rates to some extent. Nevertheless, the role and responsibilities of surgeons in this regard have not been clearly defined, and thus, there is a lack of standardized surgical strategies to reduce early endoscopic recurrence.（11） Intestinal mesentery abnormal proliferation and wrapping around the mesenteric margin is a characteristic pathological feature of Crohn's disease (CD). Recent studies have shown that mesenteric fat plays a crucial role in the development of CD (13, 14). The applicant's research team has also discovered the presence of bacteria displaced from the intestines within the mesentery, which can stimulate the proliferation of fat cells (15). Our preliminary retrospective data (pending submission) also suggests that if the mesenteric-guided margin, corresponding to the border of mesenteric abnormality, is used as the resection margin, even though an average of 10cm more intestine is removed, the postoperative endoscopic recurrence rate and clinical recurrence rate are significantly better than those of patients with the traditional limited 2cm margin (as described in the research foundation). However, there is currently no prospective randomized controlled study comparing these two margin strategies. Therefore, investigators plan to conduct a prospective multicenter randomized controlled study for patients with ileocolonic CD who undergo primary anastomosis without residual disease, comparing the postoperative endoscopic recurrence rates between mesenteric-guided margins and traditional 2cm margins, and conducting related mechanistic research to establish a high-level evidence for surgical margins that can reduce postoperative endoscopic recurrence in CD.
The significance of this research lies in addressing the issue of high endoscopic recurrence rates following surgery for Crohn's disease (CD), for which there is currently no established surgical solution. This study employs an innovative approach by using the mesenteric fat boundary as guidance for surgical resection margins, making it a novel contribution to both national and international research.
Building upon prior preliminary research, our research team aims to determine, through a prospective multicenter study, whether the use of mesentery-guided resection margins can reduce the endoscopic recurrence rate, while also exploring potential underlying mechanisms. The successful implementation of this project can provide high-level evidence for the correct selection of surgical margins in CD, fostering the development of personalized and precision surgical approaches in the treatment of CD in China, offering substantial clinical application and practical guidance.The ultimate goal of this study is to improve the long-term prognosis of CD patients and enhance their postoperative .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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mesentery-guided resection margin group
Patients will undergo surgery using the mesentery-guided resection margin approach.
mesentery-guided resection margin
Mesentery-guided resection margin where the mesentery adjacent to the intestine completely transitions from abnormal to normal upon palpation and transillumination, compared to the proximal normal mesentery. Open, laparoscopic, hand-assisted, or robotic mobilization are all acceptable, but extracorporeal resection and anastomosis are required. After intestinal mobilization , the diseased intestinal segment is exteriorized from the abdominal cavity.
traditional resection margin group
Patients will undergo surgery using the traditional resection margin approach.
traditional resection margin
2 cm proximal to the site where gross lesions disappear. After transecting the bowel, re-examine the mucosal condition; if mucosal ulcers or obvious scars are present, extend the incision until reaching the site with normal mucosa. Definition of gross lesions: Evaluation from the outer intestinal wall: The site where the tough texture, thickening, or contracture at the mesenteric edge of the intestinal wall disappears; evaluation from the intestinal lumen: The site where mucosal ulcers, fissures, or obvious scars disappear. "Mucosa appearing seemingly abnormal" is considered normal.
Interventions
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mesentery-guided resection margin
Mesentery-guided resection margin where the mesentery adjacent to the intestine completely transitions from abnormal to normal upon palpation and transillumination, compared to the proximal normal mesentery. Open, laparoscopic, hand-assisted, or robotic mobilization are all acceptable, but extracorporeal resection and anastomosis are required. After intestinal mobilization , the diseased intestinal segment is exteriorized from the abdominal cavity.
traditional resection margin
2 cm proximal to the site where gross lesions disappear. After transecting the bowel, re-examine the mucosal condition; if mucosal ulcers or obvious scars are present, extend the incision until reaching the site with normal mucosa. Definition of gross lesions: Evaluation from the outer intestinal wall: The site where the tough texture, thickening, or contracture at the mesenteric edge of the intestinal wall disappears; evaluation from the intestinal lumen: The site where mucosal ulcers, fissures, or obvious scars disappear. "Mucosa appearing seemingly abnormal" is considered normal.
Eligibility Criteria
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Inclusion Criteria
2. Ileocecal CD with localized lesions involving the terminal ileum and cecum, with a total lesion length of \<80 cm,
3. No residual lesions within 50 cm proximal to the ileocecal anastomosis,
4. Patients or their legal guardians who can understand and are willing to participate in this study, provide written informed consent, and have the ability to comply with the protocol.
Exclusion Criteria
2. Patients with primary lesions in other locations (e.g., proximal small bowel) that require surgical resection of inflamed intestinal segments other than the ileocecal region (excluding cases with affected other segments of the bowel),
3. Patients with a risk of short bowel syndrome,
4. Patients who require ileostomy formation,
5. Patients with severe anorectal lession,
6. Patients predicted to be unable to receive postoperative drug therapy,
7. Patients unable to return to the hospital for re-examination in a timely manner
8. Patients who have suffered from serious illnesses within the six months before surgery, such as myocardial infarction, active angina pectoris, congestive heart failure, or other diseases believed by the investigator to pose a risk to the patient's safety,
9. Patients with a history of malignant tumors, including melanoma (excluding localized skin cancer),
10. Patients clinically diagnosed with autoimmune diseases other than CD or with evidence of other autoimmune diseases.
11. Pregnant or lactating patients.
12. Patients who cannot be tracked at various study time points for the primary outcome measure.
Withdrawal criteria:
1. Subjects lost to follow-up or voluntarily requesting withdrawal.
2. The occurrence of anastomotic fistula after surgery that affects subsequent endoscopic evaluation.
3. Subjects considered unsuitable for further participation in the study by the investigator.
14 Years
65 Years
ALL
No
Sponsors
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Jinling Hospital, China
OTHER
Sir Run Run Shaw Hospital
OTHER
Zhongnan Hospital
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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Jia Ke
Small Intestinal Surgery, Department of General Surgery
Principal Investigators
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Jia Ke, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sixth Affiliated Hospital, Sun Yat-sen University
Locations
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Jia Ke
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Frolkis AD, Dykeman J, Negron ME, Debruyn J, Jette N, Fiest KM, Frolkis T, Barkema HW, Rioux KP, Panaccione R, Ghosh S, Wiebe S, Kaplan GG. Risk of surgery for inflammatory bowel diseases has decreased over time: a systematic review and meta-analysis of population-based studies. Gastroenterology. 2013 Nov;145(5):996-1006. doi: 10.1053/j.gastro.2013.07.041. Epub 2013 Jul 27.
Buisson A, Chevaux JB, Allen PB, Bommelaer G, Peyrin-Biroulet L. Review article: the natural history of postoperative Crohn's disease recurrence. Aliment Pharmacol Ther. 2012 Mar;35(6):625-33. doi: 10.1111/j.1365-2036.2012.05002.x. Epub 2012 Feb 7.
Frolkis AD, Lipton DS, Fiest KM, Negron ME, Dykeman J, deBruyn J, Jette N, Frolkis T, Rezaie A, Seow CH, Panaccione R, Ghosh S, Kaplan GG. Cumulative incidence of second intestinal resection in Crohn's disease: a systematic review and meta-analysis of population-based studies. Am J Gastroenterol. 2014 Nov;109(11):1739-48. doi: 10.1038/ajg.2014.297. Epub 2014 Oct 21.
Olaison G, Smedh K, Sjodahl R. Natural course of Crohn's disease after ileocolic resection: endoscopically visualised ileal ulcers preceding symptoms. Gut. 1992 Mar;33(3):331-5. doi: 10.1136/gut.33.3.331.
De Cruz P, Kamm MA, Hamilton AL, Ritchie KJ, Krejany EO, Gorelik A, Liew D, Prideaux L, Lawrance IC, Andrews JM, Bampton PA, Gibson PR, Sparrow M, Leong RW, Florin TH, Gearry RB, Radford-Smith G, Macrae FA, Debinski H, Selby W, Kronborg I, Johnston MJ, Woods R, Elliott PR, Bell SJ, Brown SJ, Connell WR, Desmond PV. Crohn's disease management after intestinal resection: a randomised trial. Lancet. 2015 Apr 11;385(9976):1406-17. doi: 10.1016/S0140-6736(14)61908-5. Epub 2014 Dec 24.
Auzolle C, Nancey S, Tran-Minh ML, Buisson A, Pariente B, Stefanescu C, Fumery M, Marteau P, Treton X, Hammoudi N; REMIND Study Group Investigators; Jouven X, Seksik P, Allez M. Male gender, active smoking and previous intestinal resection are risk factors for post-operative endoscopic recurrence in Crohn's disease: results from a prospective cohort study. Aliment Pharmacol Ther. 2018 Nov;48(9):924-932. doi: 10.1111/apt.14944. Epub 2018 Aug 20.
Magro F, Gionchetti P, Eliakim R, Ardizzone S, Armuzzi A, Barreiro-de Acosta M, Burisch J, Gecse KB, Hart AL, Hindryckx P, Langner C, Limdi JK, Pellino G, Zagorowicz E, Raine T, Harbord M, Rieder F; European Crohn's and Colitis Organisation [ECCO]. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: Definitions, Diagnosis, Extra-intestinal Manifestations, Pregnancy, Cancer Surveillance, Surgery, and Ileo-anal Pouch Disorders. J Crohns Colitis. 2017 Jun 1;11(6):649-670. doi: 10.1093/ecco-jcc/jjx008. No abstract available.
Fumery M, Dulai PS, Meirick P, Farrell AM, Ramamoorthy S, Sandborn WJ, Singh S. Systematic review with meta-analysis: recurrence of Crohn's disease after total colectomy with permanent ileostomy. Aliment Pharmacol Ther. 2017 Feb;45(3):381-390. doi: 10.1111/apt.13886. Epub 2016 Dec 8.
Fazio 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.
Riault C, Diouf M, Chatelain D, Yzet C, Turpin J, Brazier F, Dupas JL, Sabbagh C, Nguyen-Khac E, Fumery M. Positive histologic margins is a risk factor of recurrence after ileocaecal resection in Crohn's disease. Clin Res Hepatol Gastroenterol. 2021 Sep;45(5):101569. doi: 10.1016/j.clinre.2020.10.013. Epub 2020 Nov 14.
Tandon 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.
de Buck van Overstraeten A, Eshuis EJ, Vermeire S, Van Assche G, Ferrante M, D'Haens GR, Ponsioen CY, Belmans A, Buskens CJ, Wolthuis AM, Bemelman WA, D'Hoore A. Short- and medium-term outcomes following primary ileocaecal resection for Crohn's disease in two specialist centres. Br J Surg. 2017 Nov;104(12):1713-1722. doi: 10.1002/bjs.10595. Epub 2017 Jul 26.
Holt DQ, Moore GT, Strauss BJ, Hamilton AL, De Cruz P, Kamm MA. Visceral adiposity predicts post-operative Crohn's disease recurrence. Aliment Pharmacol Ther. 2017 May;45(9):1255-1264. doi: 10.1111/apt.14018. Epub 2017 Feb 28.
Li Y, Ge Y, Gong J, Zhu W, Cao L, Guo Z, Gu L, Li J. Mesenteric Lymphatic Vessel Density Is Associated with Disease Behavior and Postoperative Recurrence in Crohn's Disease. J Gastrointest Surg. 2018 Dec;22(12):2125-2132. doi: 10.1007/s11605-018-3884-9. Epub 2018 Jul 24.
He Z, Wu J, Gong J, Ke J, Ding T, Zhao W, Cheng WM, Luo Z, He Q, Zeng W, Yu J, Jiao N, Liu Y, Zheng B, Dai L, Zhi M, Wu X, Jobin C, Lan P. Microbiota in mesenteric adipose tissue from Crohn's disease promote colitis in mice. Microbiome. 2021 Nov 23;9(1):228. doi: 10.1186/s40168-021-01178-8.
Other Identifiers
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2022ZSLYEC-159
Identifier Type: -
Identifier Source: org_study_id
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