Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
2026年7月6日 更新者：Xiaolei Wang、Shanghai 10th People's Hospital
This retrospective cohort study aims to compare the efficacy of different biologics in preventing postoperative endoscopic recurrence in Crohn's disease (CD).
It plans to include 198 adult patients who underwent bowel resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025.
Patients will be divided into anti-TNF (e.g., infliximab, adalimumab) and non-anti-TNF (e.g., vedolizumab, ustekinumab) groups based on the biologic started within 6 weeks post-surgery.
The primary outcome is endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively.
Secondary outcomes include severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and histopathological changes in the bowel and mesenteric fat.
Subgroup analyses will explore treatment effects by recurrence risk stratification and resection extent.
Using retrospective data collection, the study will apply multivariate regression and survival analysis to provide real-world evidence for optimizing postoperative biologic selection.
研究概览
详细说明
This study is a retrospective cohort study aiming to compare the efficacy of different biologics in preventing endoscopic recurrence after surgery for Crohn's disease (CD).
It plans to include 198 adult CD patients who underwent intestinal resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025.
Patients will be divided into an anti-TNF group (e.g., infliximab, adalimumab) and a non-anti-TNF group (e.g., vedolizumab, ustekinumab) based on the biologic agent used within six weeks post-surgery.
The primary outcome is the rate of endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively.
Secondary outcomes include the rate of severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and pathological changes in the intestinal tissue and mesenteric fat.
Subgroup analyses will be conducted to explore differences in efficacy across varying levels of recurrence risk and resection extent.
Through retrospective data collection and statistical analyses including multivariate regression and survival analysis, this study aims to provide real-world evidence to optimize the selection of postoperative biologic therapy in clinical practice.
研究类型
观察性的
注册 (估计的)
198
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、201505
- 招聘中
- The Tenth People's Hospital of Shanghai
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接触：
- Xiaolei Wang, MD, PhD
- 电话号码：13817267967
- 邮箱：wangxiaolei@tongji.edu.cn
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接触：
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
This retrospective cohort study will include adult patients with Crohn's disease who underwent CD-related intestinal resection at Shanghai Tenth People's Hospital between January 1, 2015 and April 1, 2025.
Eligible patients initiated postoperative prophylactic biologic therapy within 6 weeks after surgery and had available postoperative follow-up data, including endoscopic assessment within 6 to 12 months after surgery or other clinical data for recurrence evaluation.
Patients will be grouped according to the type of postoperative prophylactic biologic therapy, including anti-TNF biologics and non-anti-TNF biologics.
描述
Inclusion Criteria:
- Age ≥18 years.
- Diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) guideline criteria, based on clinical, laboratory, endoscopic, radiologic, and histopathologic findings.
- Underwent Crohn's disease-related intestinal resection, including ileocolonic resection, segmental small bowel resection, or segmental colonic resection.
- Initiated postoperative prophylactic biologic therapy within 6 weeks after surgery.
- Maintained postoperative prophylactic biologic therapy for at least 3 to 6 months.
- Completed at least one evaluable postoperative ileocolonoscopy within 6 to 12 months after surgery for assessment of the Rutgeerts score, or had available clinical, radiologic, ultrasonographic, or laboratory data for evaluation of clinical recurrence.
Exclusion Criteria:
- Diagnosis of other intestinal diseases, including intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis, or intestinal malignancy.
- Intestinal surgery mainly performed for non-IBD conditions, such as intestinal malignancy.
- No postoperative endoscopic evaluation within 6 to 12 months after surgery, or endoscopic quality insufficient for Rutgeerts score assessment, and lack of adequate clinical, radiologic, ultrasonographic, or laboratory data for recurrence assessment.
- Irregular use of postoperative prophylactic therapy due to severe comorbidities, serious infection, or other reasons, making treatment efficacy difficult to evaluate.
- Other conditions considered by the investigators to be inappropriate for inclusion.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Postoperative anti-TNF biologics group
Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic anti-TNF biologic therapy within 6 weeks after surgery, including infliximab or adalimumab.
All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.
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Infliximab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice.
The recommended regimen was 5 mg/kg intravenously at weeks 0, 2, and 6, followed by maintenance treatment every 8 weeks.
Adalimumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice.
The recommended regimen was 160 mg subcutaneously at week 0, 80 mg at week 2, and 40 mg every 2 weeks from week 4 onward.
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Postoperative non-anti-TNF biologics group
Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic non-anti-TNF biologic therapy within 6 weeks after surgery, including vedolizumab or ustekinumab.
All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.
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Vedolizumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice.
The recommended regimen was 300 mg intravenously at weeks 0, 2, and 6, followed by maintenance treatment every 8 weeks.
Ustekinumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice.
The recommended regimen included a weight-based intravenous induction dose, followed by 90 mg subcutaneously every 8 weeks.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Endoscopic recurrence rate
大体时间：6 to 12 months after surgery
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The proportion of patients with endoscopic recurrence, defined as a Rutgeerts score ≥ i2 on ileocolonoscopy performed 6 to 12 months after CD-related intestinal resection.
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6 to 12 months after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Severe endoscopic recurrence rate
大体时间：6 to 12 months after surgery
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The proportion of patients with severe endoscopic recurrence, defined as a Rutgeerts score ≥ i3 on postoperative ileocolonoscopy.
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6 to 12 months after surgery
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Clinical recurrence rate
大体时间：Up to 5 years after surgery
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The proportion of patients with clinical recurrence, defined as worsening Crohn's disease-related symptoms supported by endoscopic, radiologic, ultrasonographic, laboratory, or medical record evidence, or requiring treatment escalation, hospitalization, or reoperation due to Crohn's disease activity.
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Up to 5 years after surgery
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Long-term endoscopic recurrence rate
大体时间：3 and 5 years after surgery
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The proportion of patients with endoscopic recurrence during long-term follow-up, defined as a Rutgeerts score ≥ i2 on follow-up endoscopy.
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3 and 5 years after surgery
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Crohn's disease-related rehospitalization rate
大体时间：Up to 5 years after surgery
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The proportion of patients requiring rehospitalization due to Crohn's disease activity, complications, or treatment-related problems during follow-up.
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Up to 5 years after surgery
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Crohn's disease-related reoperation rate
大体时间：Up to 5 years after surgery
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The proportion of patients requiring repeat abdominal surgery due to Crohn's disease recurrence or related complications during follow-up.
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Up to 5 years after surgery
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Drug persistence
大体时间：Up to 5 years after treatment initiation
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Time from initiation of postoperative prophylactic biologic therapy to treatment discontinuation, switch to another biologic or immunomodulator, or discontinuation due to intolerance or adverse events.
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Up to 5 years after treatment initiation
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月16日
初级完成 (估计的)
2026年9月30日
研究完成 (估计的)
2026年10月31日
研究注册日期
首次提交
2026年7月6日
首先提交符合 QC 标准的
2026年7月6日
首次发布 (实际的)
2026年7月10日
研究记录更新
最后更新发布 (实际的)
2026年7月10日
上次提交的符合 QC 标准的更新
2026年7月6日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.