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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to achieve esophageal luminal diameter to ≥14 mm
Timeframe: From enrollment to follow up, up to 2 years