NCT05521867Active, not recruiting
Endoscopic Balloon Dilation Versus Endoscopic Stricturotomy for Short Crohn's Strictures
Randomized Controlled Trial Comparing Endoscopic Balloon Dilation Versus Endoscopic Stricturotomy for Short Strictures (< 3 cm) Related to Crohn's Disease (the BEST-CD Trial)
Source: ClinicalTrials.gov · Last updated 16 Jul 2025
Brief summary (registry, in English)
Crohn's disease (CD) related strictures can be treated endoscopically by endoscopic balloon dilation (EBD) or endoscopic stricturotomy (EST). EBD is is the established endoscopic treatment for short strictures in Crohn's disease. However, roughly half had recurrent symptoms and two third require surgery after EBD. ES have been used initially for endoscopic treatment of patients for whom EBD was unsuccessful. Subsequently it was shown that ES is a better modality for treating CD related strictures (specially short and anastomotic strictures) than EBD lowering the risk of future surgery and procedure related perforation albeit with an increased risk of bleeding. ES was shown to be non-inferior to re-do surgery in chronic pouch anastomotic sinus in ulcerative colitis (UC) and ileocolic anastomotic strictures in CD thus reducing surgical morbidity. However, these two modalities have not been compared in a randomized controlled manner. We aimed to compare the two endoscopic treatments with regard to clinical success, need for surgery or additional endoscopic procedure and safety in patients with CD who have short (\<3 cm), predominantly fibrotic stenosis excluding those in the small bowel not accessible by endoscope/colonoscope.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 28 Aug 2022
- Start date
- 10 Feb 2023
- Primary completion date
- 13 Apr 2025
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Diseases
- Crohn's disease
- NCT number
- NCT05521867
What you commit to
- Study type: Interventional
- Planned participants: 96
- From 10 Feb 2023 to the primary completion date, 13 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No endoscopic therapy; and
- A combination therapy of EST and EBD at the onset
Age
- Pediatric Patients (\<18 years)
Other
- No established diagnosis of CD;
- Small bowel CD related stricture requiring enteroscopy guided dilation
- Predominantly ulcerated strictures (mixed or pure ulcerated strictures)
- Long strictures (\>3 cm)
- Pregnant or lactating mother
- Not willing to participate
Who the study is looking for
- Gastro-duodenal and ileo-colonic strictures (both de novo and anastomotic strictures)
- Short strictures (\<3 cm)
- Fibrotic or mixed stricture (predominantly fibrotic)
- Strictures treated with either EST or EBD.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asian lnstitute of Gastroenterology Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
Related publications
- Endoscopic Balloon Dilation Versus Endoscopic Stricturotomy for Short Crohn's Disease Strictures: The BEST-CD Randomized Trial.Clin Gastroenterol Hepatol · 2026 · PMID 42950934
This page is information, not medical advice. Discuss any trial with your doctor.