Gastrointestinal Neoplasms
Conditions
Keywords
Closure of GI defects
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.
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.
Interventions
PROCEDUREClosure 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.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost of each closure | Day 1 | Total cost amount for equipment used in closure of GI defect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed