NCT05082948

Migration Rates of Sutured vs Non-sutured Esophageal Stent Placement

Completed NA Last updated 23 April 2024

What this trial tests

NA trial testing Suture fixation of stent in Dysphagia, Esophageal in 46 participants. Completed in 15 March 2023.

Timeline

20 July 2021

Primary endpoint
15 March 2023

15 March 2023

Quick facts

Lead sponsor	West Virginia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	46
Start date	20 July 2021
Primary completion	15 March 2023
Estimated completion	15 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Suture fixation of stent
• Non suture

Conditions studied

• Dysphagia, Esophageal — all drugs for Dysphagia, Esophageal →
• Esophageal Cancer — all drugs for Esophageal Cancer →

Sponsor

West Virginia University

Who can join

Adults 18 to 99, any sex, with Dysphagia, Esophageal or Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

No standard approach currently exists for endoscopic esophageal stent placement, and both sutured and un-sutured techniques are employed for esophageal stent placement currently. The primary purpose of this study is to find out if suture fixation of esophageal stents is superior to non-suture fixated stent placement.

Consecutive patients who are scheduled for esophageal stent placement will be identified as potential study participants by study personnel and will be approached on the day of the procedure. Informed consent will be obtained and patients will be randomized into suture fixation and non-suture fixation groups. Patients in the suture fixation group will have their esophageal stent secured in location with two endoscopic sutures. Those in the non-suture fixation group will have no sutures placed. Main study outcome is stent migration, and rates of stent migration will be compared in the two groups.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Endoscopic suturing to prevent migration of esophageal fully covered self-expandable metal stents: a randomized controlled trial (with video).
   Singh S, Maan S, Hadi Y, Agrawal R, et al · · 2025 · cited 2× · PMID 40024292 · DOI 10.1016/j.gie.2025.02.037
2. UEG Week 2023 Moderated Posters
   · 2023