Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures

NCT ID: NCT06991049

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-14
• Study Completion Date: 2027-07-31

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

Detailed Description

This study aims to explore the safety and effectiveness of two clinical treatment approaches used to manage RBES patients-Temporary early-stent placement versus late stenting.

For normal swallowing, the esophagus (food pipe) lumen should be equal to or more than 14 mm in diameter. In those with stricture (narrowing) of the esophagus from benign causes, initial endoscopic management is serial sessions of dilation (stretching) to achieve and maintain a diameter of ≥14mm. Many strictures may not respond to this approach (refractory). Esophageal stents (18 mm - 23 mm diameter) temporarily placed for 2 weeks using an endoscope are also used dilate and remold the stricture. While in place, patients can swallow. This can save the patient from undergoing repeated dilations. Stents can be placed either late in the process of management after several traditional dilations have failed or early in the management to rapidly achieve a diameter of ≥14 mm and then continuing traditional dilations.

Although either of above two approaches can be used for the clinical management of RBES, in this study the investigators plan to randomly assign patients to start with one of the two approaches and compare outcomes.

Conditions

Refractory Benign Esophageal Strictures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Fully covered self-expandable metal esophageal stent

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Fully covered self-expandable metal esophageal stent

Intervention Type: DEVICE

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

Interventions

Fully covered self-expandable metal esophageal stent

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Kulwinder Dua, MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Study Coordinator

Role: primary

sthierfe@mcw.edu

414-805-7372

Other Identifiers

PRO00054233

Identifier Type: -

Identifier Source: org_study_id