MedTrace Logo

Migration Rates of Sutured vs Non-sutured Esophageal Stent Placement

NCT05082948 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-04-23

No results posted yet for this study

Summary

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.

Conditions

  • Dysphagia, Esophageal
  • Esophageal Cancer

Interventions

OTHER

Suture fixation of stent

Esophageal stent will be placed in the standard of care fashion by the endoscopists using standard gastroscopes. Covered self-expanding metal stent will be placed as per endoscopist preference. After esophageal stent placement, endoscopic suturing will be performed in cases of patients randomized to suture fixation.

OTHER

Non suture

Standard placement of stent without suture fixation

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • Shailendra Singh · West Virginia University

  • Arunkumar Krishnan · West Virginia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-20
Primary Completion
2023-03-15
Completion
2023-03-15

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05082948 on ClinicalTrials.gov