Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation

NCT ID: NCT04007692

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-15

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophageal Stenosis Stent Migration Suture, Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Esophageal stent placement

Intervention Type PROCEDURE

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.

Esophageal stent placement

Intervention Type PROCEDURE

Exposure of interest is standard of care esophageal stent placement

Interventions

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Esophageal stent placement

Exposure of interest is standard of care esophageal stent placement

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Barham K. Abu Dayyeh, M.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Barham K Abu Dayyeh, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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18-003817

Identifier Type: -

Identifier Source: org_study_id

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