Prospective Study Evaluating the Use of a Novel Through - the- Scope Suturing System as a Dynamic Traction Device During ESD: A Feasibility Study
Baylor College of Medicine
Summary
The goal of this prospective study at Baylor St. Luke's Medical Center is to investigate the the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric endoscopic submucosal dissection (ESD). The investigators of this study hypothesize that a dynamic traction during ESD can be less traumatic than with other traction devices.
Description
Endoscopic submucosal dissection (ESD) is the mainstay of treatment for complex gastrointestinal polyps, particularly those with a higher risk of superficial submucosal invasion. To facilitate endoscopic dissection, traction is frequently used, particularly in tough locations or when fibrosis is present \[1\]. Traction assisted ESD is particularly attractive when other techniques, such as tunneling or pocket formation, are not effective. Tissue traction can be applied by several methods including gravity, mucosal tension, water pressure, and adjusting the patient's body position \[2\]. Additi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
Inclusion Criteria: 1. The patient is ≥ 18 years old. 2. Patients can provide informed consent. 3. The patient is referred for ESD procedure of colonic or gastric neoplastic lesions and with one of the following criteria: A- Lesions with prior failed resection of any size. B- Granular lateral spreading tumors (GLST) more than 30 mm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any lesion with suspected superficial submucosal invasion. E- Subepithelial lesions. Exclusion Criteria: 1. The patient is \< 18 years old. 2. The patient refuses and/or is unable to provide c…
Interventions
- DeviceTraction Device
After circumferential incision and trimming the submucosa at the incision's edge, dissection is initiated until approximately 20 to 30% of the anal side (for colonic lesions) or oral side (for gastric lesions) of lesion has been dissected leaving a flap of at least 1 cm in length. Once the mucosal flap is created the X-tack device is introduced through the endoscope channel. The first tack is placed on the opposite wall of the lesion, the 2nd and 3rd tack will then be placed next to each other on the mucosal flap portion of the lesion. The 4th tack does not have to be placed but can be used to generate further traction at any time. Clips can be placed along the suture and clipped to the wall at any point to change angulation of traction. The sutures can then be cut and released from the tissue
Location
- Baylor College of MedicineHouston, Texas