Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation

Mayo Clinic

Status: Terminated

Conditions: Esophageal Stenosis; Suture, Complication; Stent Migration

Treatments: Procedure: Esophageal stent placement

Study type: Observational

Funder types: Other

Identifiers

NCT04007692

18-003817

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 2 patient groups

Simple interrupted suture group

Description:

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.

Treatment:

Procedure: Esophageal stent placement

Triangular suture group

Description:

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.

Treatment:

Procedure: Esophageal stent placement