๐ฌIn plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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.
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What it tests
- Fully covered self-expandable metal esophageal stent
Froedtert Hospital
Milwaukee, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.