Comparing Endoscopic Strictureplasty vs. Balloon Dilation in Crohn's Disease Strictures
Not applicable · Testing endoscopic stricturoplasty and endoscopic balloon dilation · 1 site · Second Affiliated Hospital, Zhejiang University, School of Medicine
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing endoscopic stricturoplasty (a procedure) and endoscopic balloon dilation (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 75
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Age between 18 and 75 years old. Clear evidence of primary or secondary strictures in Crohn's disease that can be identified through imaging and endoscopy (colonoscopy can reach the site).
- If the patient has previously undergone endoscopic treatment, they must have remained asymptomatic for at least one year.
- Complete or partial intestinal obstruction. Ineffectiveness of traditional and step-up treatment approaches. Stricture length less than 5 cm. A maximum of two strictures. Signed informed consent.
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 102 participants are expected to take part.
- Start date: 2024-12-16.
- Main results expected around 2025-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Remission rate of patients (1 year)
In the researchers’ words
Crohn's disease (CD) is an inflammatory bowel disease characterized by chronic ulcers, strictures, and penetrating lesions in the intestinal tract. In the early stages of the disease, inflammation and ulcers are the primary manifestations.
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 | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Enrollment | 102 (estimated) |
| Start date | 2024-12-16 |
| Primary completion (est.) | 2025-12-31 |
| First posted | 2024-01-12 |
| Last updated | 2025-06-15 |
| Official title | Comparison of Endoscopic Strictureplasty and Endoscopic Balloon Dilation for the Treatment of Crohn's Disease Intestinal Strictures: An Open-Label, Multicenter, Randomized Controlled Trial |
| ClinicalTrials.gov ID | NCT06203782 |
Interventions
- endoscopic stricturoplasty (Procedure)
Experimental Group: In the experimental group, 51 patients underwent endoscopic stricturoplasty. A transparent cap was mounted on the front end of the endoscope, and a needle knife was inserted through the working channel of the endoscope. Under direct visualization, a radial incision was made at the site of the stricture, with an effort to preserve normal mucosal tissue as much as possible. The s… - endoscopic balloon dilation (Procedure)
Control Group: In the control group, 51 patients underwent endoscopic balloon dilation. The endoscope was advanced to the site of the stricture, and a dilation guidewire was inserted. After placing the balloon, it was progressively inflated with pressure, each inflation lasting 1-2 minutes, and this process was repeated 2-3 times until the endoscope and sheath could pass through the narrowed segme…
Full eligibility criteria (from the record)
Inclusion Criteria: Age between 18 and 75 years old. Clear evidence of primary or secondary strictures in Crohn's disease that can be identified through imaging and endoscopy (colonoscopy can reach the site). If the patient has previously undergone endoscopic treatment, they must have remained asymptomatic for at least one year. Complete or partial intestinal obstruction. Ineffectiveness of traditional and step-up treatment approaches. Stricture length less than 5 cm. A maximum of two strictures. Signed informed consent. Exclusion Criteria: Strictures complicated by abscesses, fistulas, or other active lesions that are not confined to the stricture site. Strictures that have previously been treated with stents or dilation, but without symptomatic relief maintained for more than one year. Pregnancy or lactation. Inability to undergo endoscopic treatment. Severe coagulation disorders (platelet count less than 70,000, INR greater than 1.5). Concurrent advanced-stage tumors or other severe systemic comorbidities.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| 浙江大学医学院第二附属医院 | Hangzhou, Hangzhou | 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.