Migration Rates of Sutured vs Non-sutured Esophageal Stent Placement

NCT05082948 | Completed DMC

• 1 other identifier: 2101223876
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

esophageal stent; dysphagia

Outcome Measures

Primary Outcomes (1)

• Composite of stent migration or total stent dislodgement

  Stent migration will be defined as stent displacement of 20 mm or more from initial chest Xray. 20 mm has been taken as reference due to some fore-shortening that is expected with the stents, and to account for angulation and measurement related inter-radiograph variability. Inability to locate stent on chest radiograph or Esophagogastroduodenoscopy (EGD) will be defined as total stent dislodgement, which will be analyzed separately as well as included in the composite outcome.

  4 weeks

Secondary Outcomes (5)

• Total stent dislodgement

  4 weeks

• Stent Migration

  4 weeks

• Technical success

  4 weeks

• Adverse events

  3 months

• Length of procedure

  4 weeks

Other Outcomes (2)

• Cost of procedure

  3 months

• Dysphagia

  3 months

Study Arms (2)

Suture arm

EXPERIMENTAL

Esophageal stent will be placed in standard of care fashion by the endoscopists using standard gastroscopes. After esophageal stent placement, endoscopic suturing will be performed in cases of patients randomized to suture fixation.

Other: Suture fixation of stent

Non-suture

PLACEBO COMPARATOR

Esophageal stent will be placed in standard of care fashion by the endoscopists using standard gastroscopes. No sutures will be placed to fixate the stent

Other: Non suture

Interventions

Suture fixation of stent OTHER

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.

Suture arm

Non suture OTHER

Standard placement of stent without suture fixation

Non-suture

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• Indication for esophageal stent placement

You may not qualify if:

• Presence of any contraindication to esophageal stent placement
• Incarceration
• Inability to tolerate anesthesia
• Pregnant status

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26508, United States

Location

Related Publications (1)

• Singh S, Maan S, Hadi Y, Agrawal R, Adekolu AA, Cohen EM, Ali FS, Fang W, Markovich B, Krafft M, Thakkar S. Endoscopic suturing to prevent migration of esophageal fully covered self-expandable metal stents: a randomized controlled trial (with video). Gastrointest Endosc. 2025 Oct;102(4):525-535.e4. doi: 10.1016/j.gie.2025.02.037. Epub 2025 Feb 28.

  PMID: 40024292 DERIVED

MeSH Terms

Conditions

Deglutition Disorders; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Shailendra Singh

  West Virginia University

  PRINCIPAL INVESTIGATOR

• Arunkumar Krishnan

  West Virginia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor & Director, Bariatric Endoscopy

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: July 20, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)