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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Through-the-Scope clip group | Experimental | Through the scope Dual Action Tissue Clip (DAT) clipping equipment and technique performed in closure of GI defect area after polyp removal. |
|
| X-Tack suturing group | Active Comparator | Use of Endoscopic Helix Tacking System (X-Tack) by Apollo Endosurgery for the closure of GI defect after polyp removal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closure type | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of each closure | Total cost amount for equipment used in closure of GI defect | Day 1 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40640617 | Derived | Jawaid S, Khalaf M, Ayoub F, Zabad N, Fikry A, Daba G, Mercado M, Keihanian T, Othman M. RCT comparing the clinical efficacy and costs of two tissue approximation devices in the closure of large post-endoscopic resection defects. Surg Endosc. 2025 Aug;39(8):5442-5453. doi: 10.1007/s00464-025-11876-1. Epub 2025 Jul 10. |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Day 1 (End of procedure) |
| D005767 |
| Gastrointestinal Diseases |