Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation

• Conditions: Esophageal Stenosis; Stent Migration; Suture, Complication
• Interventions: Procedure: Esophageal stent placement

• Registration Number: NCT04007692
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Study Start: 2019-08-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Simple interrupted suture group	Esophageal stent placement	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.
Triangular suture group	Esophageal stent placement	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.

Primary Outcome Measures

Name	Time	Method
Stent migration rate	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
Adverse Events	4 weeks	Number of adverse events reported

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States