Comparing surgery and biologics for treating stricturing Crohn's disease
Early Versus Delayed Surgery for Symptomatic Stricturing Crohn's Disease : an Open-label, Single-center, Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Jinling Hospital, China Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05421455 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nanjing, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.