Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
Recruiting
N/AInterventional Study
Refractory Benign Esophageal Strictures
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Medical College of Wisconsin · Other
Who this trial is looking for
This trial is looking for people with troublesome esophageal strictures to compare two treatment options. Participants will either receive early stent placement or frequent dilations followed by stenting if needed.
Are You a Good Fit for This Trial?
You may be able to join if
I can give informed and written consent.
I can keep follow-up appointments for at least 2 years.
I have a biopsy-proven benign esophageal stricture.
I have dysphagia (difficulty swallowing) that is moderate or severe.
I am fit for an upper GI endoscopy.
I have a documented esophageal stricture with a diameter less than 14 mm.
You may not be able to join if
I have minimal dysphagia (mild difficulty swallowing).
I have neuromuscular dysphagia.
I am pregnant or planning to get pregnant during the study.
I have a malignant esophageal stricture.
I am currently receiving radiation therapy.
I have active esophagitis that is not healed.
I have esophageal strictures with fistulas or leaks.
I cannot give informed consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
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Status
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 lumin…
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.
Contacts
No contact information available.
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