Recruiting

Dilation & Stent

Sponsor:

Medical College of Wisconsin

Code:

NCT06991049

Conditions

Refractory Benign Esophageal Strictures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fully covered self-expandable metal esophageal stent

Study Details

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

Conditions

Refractory Benign Esophageal Strictures

Study ID

NCT06991049

Start date

Oct 14, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Mar 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Late-stent approach

Repeated dilations at weekly intervals, and based on the response, the intervals between dilations are adjusted, and if still no response, place a removable FCSEMS (18 mm diameter). The stent will be removed in 2 weeks followed again by weekly dilations till less than one dilation is needed every 3 months to maintain a luminal diameter of 14 mm or more.

active comparator: Early-stent approach

Removable FCSEMS (18 mm diameter) placed on index endoscopy and removed after 2 weeks followed by weekly dilations till less than one dilation is needed every 3 months to maintain a luminal diameter of 14 mm or more.

Interventions

Fully covered self-expandable metal esophageal stent

Esophageal stent placement for patients with benign esophageal strictures not responding to endoscopic dilations.

Primary outcome measure

  • Time to achieve esophageal luminal diameter to ≥14 mm [ Time Frame: From enrollment to follow up, up to 2 years ]

Central Contacts and Locations

Locations

Froedtert Hospital

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Study Coordinator

414-805-7372sthierfe@mcw.edu

Principal Investigator:

Kulwinder Dua, M.D.

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • Refractory Benign Esophageal Strictures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-10-30.