Prediction of Postoperative Recurrence in Crohn's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
This multicenter prospective observational cohort study aims to develop and validate a multimodal prediction model for postoperative recurrence in patients with Crohn's disease.
Patients with Crohn's disease who undergo intestinal resection will be enrolled and followed after surgery. Residual surgical tissue that would otherwise be discarded, together with routinely collected clinical data and biological samples, will be used for research. Multi-omics analyses, including single-cell transcriptomics and spatial transcriptomics, will be performed to identify biological features associated with postoperative recurrence.
Participants with Crohn's disease will be followed for clinical, endoscopic, and imaging recurrence after surgery. The study will use data from a screening cohort to develop a prediction model and a validation cohort to evaluate the performance of the model. A control group consisting of patients undergoing intestinal resection for conditions such as colorectal tumors or diverticular disease will also be included for comparative molecular analyses.
No treatment will be assigned by the study protocol. All treatment decisions will be made by the treating physicians according to routine clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Crohn's disease according to the diagnostic criteria of the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing).
Patients with Crohn's disease who require surgical resection of the diseased intestinal segment because of complications such as stricturing or penetrating disease, or because of failure of medical therapy.
Disqualifiers
Uncertain diagnosis of Crohn's disease.
Clinical history or medical records are substantially incomplete, making it impossible to determine the time of recurrence or whether postoperative recurrence occurred.
Coexisting inflammatory bowel disease or other rheumatic or autoimmune diseases.
Substantially incomplete clinical history or medical records.
Trial population
Hospitalized or outpatient patients who require intestinal resection will be screened by the investigators. The study population includes patients with Crohn's disease undergoing clinically indicated intestinal resection and non-IBD control participants undergoing intestinal resection for conditions such as colorectal tumors or diverticular disease. Patients with Crohn's disease will be enrolled into a screening cohort or a multicenter validation cohort.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intestinal Resection
Procedure/SurgeryParticipants undergo intestinal resection as clinically indicated as part of routine medical care. The surgical procedure is not assigned by the study protocol. Residual surgical tissue that would otherwise be discarded may be collected for research analyses.
Biospecimen Collection
Procedure/SurgeryResidual surgical tissue and biological samples are collected for research. Surgical tissue used for research consists of residual specimens remaining after routine clinical pathological examination. Samples may be used for transcriptomic, single-cell transcriptomic, spatial transcriptomic, proteomic, microbiome, metabolomic, and other multi-omics analyses.
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: Screening Cohort2 interventions
Group B: Validation Cohort2 interventions
Group C: Non-IBD Control Cohort2 interventions
Trial outcomes
Primary outcomes
1
Clinical Recurrence Rate at 6 Months
Clinical recurrence is defined as the recurrence of clinical manifestations or complications such as abdominal pain, diarrhea, hematochezia, fistula, or perforation, together with a Harvey-Bradshaw Index (HBI) \>4 or Crohn's Disease Activity Index (CDAI) \>150, with recurrence confirmed by endoscopic or imaging assessment. The outcome is reported as the proportion of participants with clinical recurrence.
Time frame
6 months after intestinal resection2
Endoscopic Recurrence Rate at 6 Months
Endoscopic recurrence is defined as a Rutgeerts score of i2 or higher on postoperative endoscopy after complete resection of macroscopically diseased bowel. The outcome is reported as the proportion of participants meeting the criterion for endoscopic recurrence.
Time frame
6 months after intestinal resectionSecondary outcomes
1
Endoscopic Recurrence Rate at 1 Year
Endoscopic recurrence is defined as a Rutgeerts score of i2 or higher on postoperative endoscopy after complete resection of macroscopically diseased bowel. The outcome is reported as the proportion of participants meeting the criterion for endoscopic recurrence.
Time frame
1 year after intestinal resection2
Clinical Recurrence Rate at 1 Year
Clinical recurrence is defined as recurrence of clinical manifestations or complications such as abdominal pain, diarrhea, hematochezia, fistula, or perforation, together with a Harvey-Bradshaw Index (HBI) \>4 or Crohn's Disease Activity Index (CDAI) \>150, with recurrence confirmed by endoscopic or imaging assessment. The outcome is reported as the proportion of participants with clinical recurrence.
Time frame
1 year after intestinal resection3
Imaging Recurrence Rate at 1 Year
Imaging recurrence is defined as a score of 2 or higher on computed tomography enterography (CTE) or magnetic resonance enterography (MRE) after surgical resection of the diseased bowel. The outcome is reported as the proportion of participants meeting the imaging recurrence criterion.
Time frame
1 year after intestinal resection4
Imaging Recurrence Rate at 6 Months
Imaging recurrence is defined as a score of 2 or higher on computed tomography enterography (CTE) or magnetic resonance enterography (MRE) after surgical resection of the diseased bowel. The outcome is reported as the proportion of participants meeting the imaging recurrence criterion.
Time frame
6 months after intestinal resectionSponsors and contacts
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Source ClinicalTrials.gov