Actively Recruiting
Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
Led by Medical College of Wisconsin · Updated on 2025-10-30
20
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This project is being done to compare two current treatment clinical options for management of RBES: 1) Frequent dilations followed by temporary esophageal stent placement if dilations fail, or 2) Early stent placement followed by dilations
CONDITIONS
Official Title
Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed and written consent.
- Able to keep follow up appointments as per protocol (minimum 2 years).
- Biopsy proven benign esophageal stricture.
- Dysphagia (grade 2 and above).
- Fit to undergo upper GI endoscopy.
- Documented esophageal stricture with a luminal diameter <14 mm at index endoscopy.
You will not qualify if you...
- Minimal dysphagia (grade 0-1).
- Neuromuscular dysphagia (such as achalasia, oro-pharyngeal dysphagia post-stroke, crico-pharyngeal bar, Zenker diverticulum etc.).
- Pregnant or planning to be pregnant during the study period.
- Malignant or indeterminate esophageal stricture.
- Actively receiving radiation therapy.
- Persistent associated active esophagitis that has not yet healed.
- Esophageal strictures associated with fistula/leaks/current or prior perforation.
- Eosinophilic esophagitis.
- Associated esophageal varices.
- No other malignancy limiting life expectancy.
- Patients in whom placing esophageal stents is not possible/contraindicated (such as high cervical esophageal strictures, active bleeding, metal allergy, tortuous esophagus, pseudodiverticulum with stricture).
- Previous esophageal stent tried over 2 months ago.
- Significant comorbidities making patient high risk for upper GI endoscopy.
- Unable to give informed consent.
- Cannot keep follow up appointments as per protocol.
- Procedures and stents not covered by patient's insurance.
- Patients who choose to proceed with a specific approach after discussion and decline participation in randomization.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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