Preventing Esophageal Stent Migration in Esophageal Strictures

Comparison of no Fixation vs. Stent Suturing vs. OTSC Stentfix in Preventing Esophageal Stent Migration in Esophageal Strictures

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 Overview

• Status: Withdrawn
• Conditions: Stent Migration
• Intervention / Treatment: Procedure: Stent Suturing / Endoscopic Clips; Device: OTSC Stentfix

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofia Yuen, MD, MBA; Phone Number: 212-263-3095; Email: sofia.yuen@nyulangone.org
• Study Contact Backup: Name: Lauren Khanna, MD; Phone Number: 212-263-3095; Email: Lauren.Khanna@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
      • Contact: Sofia Yuen, MD, MBA; Phone Number: 212-263-3095; Email: sofia.yuen@nyulangone.org
      • Sub-Investigator: Lauren Khanna, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No fixation
Active Comparator: Stent Suturing	Procedure: Stent Suturing / Endoscopic Clips; Stent placement with fixation of the esophageal stent using sutures / endoscopic clips.
Experimental: OTSC Stentfix	Device: OTSC Stentfix; Stent placement with fixation of the esophageal stent using OTSC Stentfix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants who Experience Stent Migration	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Procedural Time	Time it takes to complete standard of care upper endoscopy with standard of care stent placement with or without fixation.	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.	Baseline, Week 48

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Stenosis
• Other Study ID Numbers: 20-01901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to sofia.yuen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes