Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation

NCT04007692 | Terminated

• 1 other identifier: 18-003817
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are trying to determine which suturing pattern for esophageal stent placement is more effective in a randomized fashion as currently what suturing pattern to use is an arbitrary decision.

Conditions

Esophageal Stenosis; Stent Migration; Suture, Complication

Keywords

Esophageal stenosis; Endoscopic suturing; Esophageal stent fixation; Stent migration

Outcome Measures

Primary Outcomes (2)

• Stent migration rate

  Number of participants with stent migration as assessed by objective evidence of stent migration on endoscopy at 3-4 weeks after esophageal stent placement

  4 weeks post stent placement

• Adverse Events

  Number of adverse events reported

  4 weeks

Study Arms (2)

Simple interrupted suture group

Participants will have a simple interrupted suturing pattern, determined by care provider, at the time of esophageal stent placement for esophageal stent fixation as part of standard care and will have an endoscopy at 3-4 weeks after the stent placement as part of a routine follow-up.

Procedure: Esophageal stent placement

Triangular suture group

Participants will have a triangular suturing pattern, determined by care provider, at the time of esophageal stent placement for esophageal stent fixation as part of standard care and will have an endoscopy at 3-4 weeks after the stent placement as part of a routine follow-up.

Procedure: Esophageal stent placement

Interventions

Esophageal stent placement PROCEDURE

Exposure of interest is standard of care esophageal stent placement

Simple interrupted suture group; Triangular suture group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Non-vulnerable adults who are receiving an endoscopically placed esophageal stent for any indication at Mayo Clinic Rochester.

You may qualify if:

• Subjects aged 18 or above
• Subjects undergoing esophageal stent placement with any indication

You may not qualify if:

• Imprisoned individuals,
• Institutionalized patients
• Inability or unwillingness of individual

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Barham K Abu Dayyeh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: August 15, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)