Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures (NCT06991049) | Clinical Trial Compass
RecruitingNot Applicable
Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
United States20 participantsStarted 2025-10-14
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…
What they're measuring
1
Time to achieve esophageal luminal diameter to ≥14 mm
Timeframe: From enrollment to follow up, up to 2 years