RecruitingNot ApplicableNCT06991049
Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
Early Versus Late Endoscopic Temporary Stenting for Management of Refractory Benign Esophageal Strictures
Sponsor
Medical College of Wisconsin
Enrollment
20 participants
Start Date
Oct 14, 2025
Study Type
INTERVENTIONAL
Conditions
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) Early stent placement followed by dilations
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria17
- 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.
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Interventions
DEVICEFully covered self-expandable metal esophageal stent
Esophageal stent placement for patients with benign esophageal strictures not responding to endoscopic dilations.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06991049