Feasibility and Prospective Study of a Dynamic Traction Device for Use During ESD

Baylor College of Medicine

Status: Not yet enrolling

Conditions: Gastrointestinal Neoplasms

Treatments: Device: Traction Device

Study type: Observational

Funder types: Other

Identifiers

NCT06747988

H-56820

Details and patient eligibility

About

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.

Full 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]. Additionally, traction can also be applied using devices such as clip and line, snare, band assisted or using dedicated over-the-scope devices, which can be cumbersome and costly. Despite multiple publications about the efficacy of traction devices in the East, there are few published data from the West [3]. Furthermore, an easy to use through the scope (TTS) dynamic traction device has yet to be developed. Recently, a novel TTS helix tack and suture device (X-tack, Apollo Endosurgery, Austin, Tex, USA) was FDA approved to help facilitate closure of post-resection defects [4]. However, clinical experience suggests the tack and suture system can also be used as a form of dynamic traction during ESD, similar to effective techniques using traditional suture-pulley systems for countertraction during ESD [5]. The traditional suture-pulley system, however, can be cumbersome to assemble as multiple parts are needed to configure it appropriately [6]. Additionally, attaching the suture to the designated areas requires use of multiple costly clips and if repositioning is needed, removal of the clip can be traumatic to the tissue. With the novel TTS suture system (X-tack), four tacks are already assembled along one suture line, thus a suture-pulley countertraction system can be employed without having to assemble multiple parts. In addition, the degree and angulation of traction can be altered simply by pulling, releasing or even redirecting the suture towards a different axis, supporting a dynamic traction during ESD. Finally, removal of the tack, if required, can be less traumatic than with other traction devices. Despite its potential advantages, use of X-tack as countertraction pulley system during ESD has not been formally studied. We looked to investigate the efficacy and safety of using the novel TTS helix tack suture device as a dynamic traction device during colon and gastric ESD.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 consent.
3. The patient is a pregnant woman.
4. Lesions with morphology: pedunculated type (Paris Ip, Ips).
5. Appendiceal orifice or IC valve lesions
6. Patients with lesions removed with other techniques besides ESD (submucosal tunneling technique [STER] or EMR).