Status:
RECRUITING
Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Refractory Benign Esophageal Strictures
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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) Ear...
Detailed Description
This study aims to explore the safety and effectiveness of two clinical treatment approaches used to manage RBES patients-Temporary early-stent placement versus late stenting. For normal swallowing, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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, after comprehensive discussion and explanation of both the early-stent and late-stent approaches, choose to proceed with a specific approach and decline participation in randomization.
Key Trial Info
Start Date :
October 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06991049
Start Date
October 14 2025
End Date
July 1 2027
Last Update
October 30 2025
Active Locations (1)
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1
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226