Early versus late esophageal stenting for stubborn benign narrowings

Early Versus Late Endoscopic Temporary Stenting for Management of Refractory Benign Esophageal Strictures

This trial tests whether putting in a temporary esophageal stent early or waiting to use a stent only after repeated dilations work better for people with stubborn benign esophageal strictures.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medical College of Wisconsin (other)
• Drugs / interventions: radiation
• Locations: 1 site (Milwaukee, Wisconsin)
• Trial ID: NCT06991049 on ClinicalTrials.gov

What this trial studies

Researchers will randomly assign patients with biopsy-proven refractory benign esophageal strictures and significant swallowing difficulty to one of two approaches: early temporary placement of a fully covered self-expandable metal stent or the usual strategy of repeated dilations with stenting reserved for failures. Stents (18–23 mm) are placed endoscopically for a short period (about 2 weeks) while patients continue standard care and follow-up. The study will compare safety, symptom relief, need for repeat dilations, and complications over scheduled follow-up visits. Outcomes aim to determine whether earlier stenting reduces procedures and improves swallowing compared with late stenting.

Who should consider this trial

Good fit: Ideal candidates are adults with biopsy-proven benign esophageal strictures causing at least moderate dysphagia, a lumen under 14 mm at endoscopy, fit for upper endoscopy, and able to attend follow-up visits for the study period.

Not a fit: Patients with minimal or neuromuscular dysphagia, active unhealed esophagitis, malignant or indeterminate strictures, esophageal varices, pregnancy, or contraindications to stent placement are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could reduce the number of repeated dilations and restore swallowing more quickly for people with refractory benign strictures.

How similar studies have performed: Temporary esophageal stenting is used in clinical practice and observational reports suggest it can reduce the need for repeat dilations, but randomized comparisons of early versus late stenting are limited.

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.

Where this trial is running

Milwaukee, Wisconsin

• Froedtert Hospital — Milwaukee, Wisconsin, United States (RECRUITING)

Conditions: Refractory Benign Esophageal Strictures