Preventing Esophageal Stent Migration in Esophageal Strictures

NYU Langone Health

Overview

This study aims to assess the efficacy and rate of stent migration in standard of care esophageal stents that are not fixed, compared to those that are fixed with either standard of care OTSC stentfix or standard of care stent placement with suturing in both benign and malignant esophageal strictures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Stent Migration

Interventions

OTSC StentfixDEVICE

Stent placement with fixation of the esophageal stent using OTSC Stentfix.

Stent Suturing / Endoscopic ClipsPROCEDURE

Stent placement with fixation of the esophageal stent using sutures / endoscopic clips.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The study population will include any adult (18 years +) who will undergo standard of care esophageal stent placement for benign or malignant esophageal strictures as either an inpatient or outpatient at NYULH. 2. The participant is able to consent to stent placements with fixation or without fixation and study procedures, verified by signature on the informed consent form. 3. Willing to comply with all study procedures and be available for the duration of the study. 4. English and Non-English speaking participants. Exclusion Criteria: 1\. Patients who have strictures treated with luman apposing stents.

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Number of Participants who Experience Stent Migration

Time frame: Week 48

Secondary Outcomes

Total Procedural Time

Time it takes to complete standard of care upper endoscopy with standard of care stent placement with or without fixation.

Time frame: 120 minutes

Change in Score on Dysphagia Outcome and Severity Scale (DOSS)

DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia. The total range of score is 1-7; a lower score indicates more severe symptoms of dysphagia.

Time frame: Baseline, Week 48

Data from ClinicalTrials.gov

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