Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation

September 11, 2024 updated by: Barham K. Abu Dayyeh, M.D., Mayo Clinic

Suturing Pattern for Endolumenal Stenting Procedures

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The participants who are receiving esophageal stent placement will be prospectively randomized to receive two suturing patterns (simple interrupted pattern and triangular pattern) for endoscopic esophageal stent fixation. We will investigate rate of the stent migration at 3-4 weeks by endoscopy after the stent placement as part of routine clinical care. Data of the duration of endoscopic suturing, adverse events, details of the stent used, indication for use will also be collected.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Exposure of interest is standard of care 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
Exposure of interest is standard of care esophageal stent placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent migration rate
Time Frame: 4 weeks post stent placement
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
Time Frame: 4 weeks
Number of adverse events reported
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Barham K Abu Dayyeh, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 11, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-003817

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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