Comparing surgery and biologics for treating stricturing Crohn's disease
Official title: Surgery Versus Biologics for Symptomatic Stricturing Crohn's Disease : an Open-label, Single-center, Randomized Controlled Trial
Run by Jinling Hospital, China · NCT05421455 · Data updated 2026-11-12
This study is testing whether surgery or biologic treatments work better for people with stricturing Crohn's disease who haven't found relief with regular medications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 138 (estimated) |
| Sponsor | Jinling Hospital, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | June 9, 2022 |
| Main results expected | July 1, 2026 |
| Study ends | June 1, 2030 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT05421455 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with stricturing Crohn's disease who experience intestinal obstructive symptoms and have not achieved remission with traditional therapies.
✕Probably not a fit
Patients with complete obstruction, contraindications for biologics, or those who have successfully responded to traditional treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of surgical intervention versus biologic therapies in patients with stricturing Crohn's disease who have not responded to traditional medications. Participants will be assessed for intestinal obstructive symptoms and confirmed strictures, and will be randomly assigned to receive either surgery or biologics. The goal is to determine which treatment option provides better outcomes for managing symptoms and improving quality of life in these patients.
Why it matters
Potential benefit: If successful, this study could help identify the most effective treatment approach for patients with stricturing Crohn's disease, potentially improving their quality of life.
How similar studies have gone: While there is ongoing debate about the best management strategies for stricturing Crohn's disease, this specific comparison of surgery versus biologics is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. with intestinal obstructive symptoms; 2. confirmed intestinal strictures; 3. traditional drugs failed to induce remission; 4. envidence of active bowel inflammation; 5. inappropriate for EBD; 6. acquirement of written informed consent of participant; Exclusion Criteria: 1. unsuccessful medical treatment of intestinal obstruction; 2. complete obstruction; 3. contraindication for biologics; 4. penetrating disease; 5. short smaal bowel; 6. suspicion of bowel tumor; 7. no confirmed strictures; 8. comitant severe disese of other system; 9. obstructive symptoms under over 2 targets of biologics; 10. successful treatment with traditional drugs; 11. participate other clinical research.
Where it's running
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Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Weinming Zhu, Ph.D.
- Email: juwiming@nju.edu.cn
- Phone: +86025-80860036
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.