Early Versus Late Endoscopic Temporary Stenting for Management of Refractory Benign Esophageal Strictures
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Wisconsin
Froedtert Hospital
RECRUITING
Milwaukee
Time Frame
Start Date: 2025-10-14
Estimated Completion Date: 2027-07
Participants
Target number of participants: 20
Treatments
Active_comparator: Late-stent approach
Repeated dilations at weekly intervals, and based on the response, the intervals between dilations are adjusted, and if still no response, place a removable FCSEMS (18 mm diameter). The stent will be removed in 2 weeks followed again by weekly dilations till less than one dilation is needed every 3 months to maintain a luminal diameter of 14 mm or more.
Active_comparator: Early-stent approach
Removable FCSEMS (18 mm diameter) placed on index endoscopy and removed after 2 weeks followed by weekly dilations till less than one dilation is needed every 3 months to maintain a luminal diameter of 14 mm or more.
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin