Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures

Launched by MEDICAL COLLEGE OF WISCONSIN · May 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment options for people with a condition called refractory benign esophageal strictures, which makes it difficult to swallow. The trial aims to find out whether placing an esophageal stent early in the treatment process is better than first trying frequent dilations (a procedure to widen the esophagus) and only using a stent later if those dilations don’t work.

To participate in the trial, you need to be between the ages of 65 and 74 and have a confirmed diagnosis of a benign esophageal stricture that is causing significant swallowing difficulties. You also need to be able to attend follow-up appointments for at least two years. If you join, you will receive one of the two treatment options and will be monitored closely throughout the study. It’s important to know that if you have certain other medical conditions, are pregnant, or have had previous treatments that disqualify you, you won’t be able to participate. Overall, this trial could help improve future treatments for this swallowing condition.

Gender

ALL

Eligibility criteria

• 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 the early-stent and late-stent approaches, choose to proceed with a specific approach and decline participation in randomization.