Cost-effective Analysis of Two Approximation Devices in Closure of Gastrointestinal Defects
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Through-the-Scope clip group 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
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.
|
| Active Comparator: X-Tack suturing group Use of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal. |
Procedure: Closure type
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.
|
Outcome Measures
Primary Outcome Measures
- Cost of each closure [Day 1]
Total cost amount for equipment used in closure of GI defect
Secondary Outcome Measures
- Rate of complete closure of GI defect [Day 1 (end of procedure)]
Complete closure achieved by assigned closure type as assessed by performing physician
- Successful Tissue approximation [Day 1 (End of procedure)]
Less than or equal to 15mm of visible resection bed at its widest portion after the device is used for tissue approximation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is greater than or equal to 18 years of age.
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Patient can provide informed consent.
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Patient is referred for endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) of gastric, small bowel, or colorectal lesion.
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Post resection defect > 3cm.
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Lesion 2cm or greater from the dentate line.
Exclusion Criteria:
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Patient is < 18 years of age.
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Patient refused and/or unable to provide consent.
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Patient is pregnant.
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Patient is currently incarcerated
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Baylor College of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-50701