Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects

Baylor College of Medicine

Status: Completed

Conditions: Gastrointestinal Neoplasms

Treatments: Procedure: Closure type

Study type: Interventional

Funder types: Other

Identifiers

NCT05163665

H-50701

Details and patient eligibility

About

This is a prospective, randomized research trial that aims to evaluate the clinical results of two different approximation methods to close the tissue defect caused by removing gastrointestinal polyps.

Full description

Closure of GI defects after endoscopic resection decreases the rate of post resection bleeding. Traditionally, standard TTS clips have been used to close GI wall defects with some success. However, complete apposition of the resection wall edges occurs only 68% of the time. Endoscopic suturing with the traditional Overstitch device can achieve complete closure in almost 100% of defects. However, this device is costly, requires the use of a double channel therapeutic endoscope, and at times can be difficult to maneuver. Recently, a novel FDA approved TTS tissue helix and suture device (X-tack) was developed to overcome the challenges of the traditional Overstitch device. Animal models have demonstrated the X-tack system is superior to TTS in effecting large mucosal defects and maintain similar durability. At BCM, we have been using the X-tack system routinely in closure of GI defects.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is greater than or equal to 18 years of age.
• Patient can provide informed consent.
• Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric, small bowel, or colorectal lesion.
• Post resection defect > 3cm.
• Lesion 2cm or greater from the dentate line.

Exclusion criteria

• Patient is < 18 years of age.
• Patient refused and/or unable to provide consent.
• Patient is pregnant.
• Patient is currently incarcerated

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Through-the-Scope clip group

Experimental group

Description:

Through the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal.

Treatment:

Procedure: Closure type

X-Tack suturing group

Active Comparator group

Description:

Use of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal.

Treatment:

Procedure: Closure type