Surgery vs Biologics for Treating Stricturing CD--a RCT
Not applicable · Testing Group A and Group B · 1 site · Zhu Weiming
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Group A (a drug) and Group B (a procedure) as a possible treatment. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 60
- Any sex
Some of the main requirements, copied from the record:
- with intestinal obstructive symptoms;
- confirmed intestinal strictures;
- traditional drugs failed to induce remission;
Plus 3 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 138 participants are expected to take part.
- Start date: 2022-06-09.
- Main results expected around 2026-07-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- clinical remmision rate within 1 year (within 1 year)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Zhu Weiming |
| Enrollment | 138 (estimated) |
| Start date | 2022-06-09 |
| Primary completion (est.) | 2026-07-01 |
| First posted | 2022-06-16 |
| Last updated | 2026-07-09 |
| Official title | Surgery Versus Biologics for Symptomatic Stricturing Crohn's Disease : an Open-label, Single-center, Randomized Controlled Trial |
| ClinicalTrials.gov ID | NCT05421455 |
Interventions
- Group A (Drug)
treat participants with biologics - Group B (Procedure)
treat participants with surgery
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Department of General Surgery, Jinling hosptal,Medical School of Nanjing University | Nanjing, Jiangsu | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.