Mesenteric Surgical Margin for Crohn's Disease Endoscopic Recurrence
Recruiting · NCT06241170 · Interventional (participants receive a specific treatment) · Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Despite significant advancements in the treatment of Crohn's disease (CD), approximately 50% of patients undergo surgical intervention within ten years of diagnosis. Furthermore, more than 70% of these patients experience endoscopic recurrence within one year after surgery. This subset of patients often faces a poorer long-term prognosis and requires long-term intensified medical therapy. Therefore, reducing early postoperative endoscopic recurrence has remained a crucial focus in CD research. 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.
Who can take part
Inclusion criteria
- Patients with a clear diagnosis of CD who meet the surgical indications and will undergo one-stage ileocecal resection,
- Ileocecal CD with localized lesions involving the terminal ileum and cecum, with a total lesion length of \<80 cm,
- No residual lesions within 50 cm proximal to the ileocecal anastomosis,
- 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
- Patients with a history of ileocecal resection,
- 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),
- Patients with a risk of short bowel syndrome,
- Patients who require ileostomy formation,
- Patients with severe anorectal lession,
- Patients predicted to be unable to receive postoperative drug therapy,
- Patients unable to return to the hospital for re-examination in a timely manner
- 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,
- Patients with a history of malignant tumors, including melanoma (excluding localized skin cancer),
- Patients clinically diagnosed with autoimmune diseases other than CD or with evidence of other autoimmune diseases.
- Pregnant or lactating patients.
- Patients who cannot be tracked at various study time points for the primary outcome measure.
- Withdrawal criteria:
- Subjects lost to follow-up or voluntarily requesting withdrawal.
- The occurrence of anastomotic fistula after surgery that affects subsequent endoscopic evaluation.
- Subjects considered unsuitable for further participation in the study by the investigator.
Where it is running
1 location listed.
- Jia Ke - Guangzhou, Guangdong, China