NCT06991049 Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures
| NCT ID | NCT06991049 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical College of Wisconsin |
| Condition | Refractory Benign Esophageal Strictures |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-14 |
| Primary Completion | 2027-03-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-10-14 with a primary completion date of 2027-03-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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.
Frequently Asked Questions
Who can join the NCT06991049 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Refractory Benign Esophageal Strictures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06991049 currently recruiting?
Yes, NCT06991049 is actively recruiting participants. Visit ClinicalTrials.gov or contact Medical College of Wisconsin to inquire about joining.
Where is the NCT06991049 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT06991049 clinical trial?
NCT06991049 is sponsored by Medical College of Wisconsin. The trial plans to enroll 20 participants.