NCT05421455 Surgery vs Biologics for Treating Stricturing CD--a RCT
| NCT ID | NCT05421455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhu Weiming |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2022-06-09 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 138 participants in total. It began in 2022-06-09 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05421455 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05421455 currently recruiting?
Yes, NCT05421455 is actively recruiting participants. Contact the research team at juwiming@nju.edu.cn for enrollment information.
Where is the NCT05421455 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05421455 clinical trial?
NCT05421455 is sponsored by Zhu Weiming. The trial plans to enroll 138 participants.