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Compares treatment options for Refractory Benign Esophageal Strictures
Official title Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
ClinicalTrials.gov ID: NCT06991049
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.