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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastrointestinal Neoplasms

Intervention / Treatment
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* Procedure: Closure type


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Through-the-Scope clip group<br>Through the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal. | Procedure: Closure type<br>* Patients will have their endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) as per standard-of-care. Afterwards, patient will receive one of two intervention options for the closure of the GI defect following polyp removal.<br>|
| Active Comparator: X-Tack suturing group<br>Use of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal. | Procedure: Closure type<br>* Patients will have their endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR) as per standard-of-care. Afterwards, patient will receive one of two intervention options for the closure of the GI defect following polyp removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of each closure | Total cost amount for equipment used in closure of GI defect | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete closure of GI defect | Complete closure achieved by assigned closure type as assessed by performing physician | Day 1 (end of procedure) | 
| Successful Tissue approximation | Less than or equal to 15mm of visible resection bed at its widest portion after the device is used for tissue approximation | Day 1 (End of procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closure of GI defects