Clinical trial NCT06747988: Feasibility and Prospective Study of a Dynamic Traction Device for Use During ESD
Official title: Prospective Study Evaluating the Use of a Novel Through - the- Scope Suturing System as a Dynamic Traction Device During ESD: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastrointestinal Neoplasms
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing ESD procedure at Baylor St. Luke's Medical Center - Houston, TX.

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Technical success
timeFrame: Day 1 (procedure day)
Secondary outcomes:
measure: Dissection speed
timeFrame: Day 1 (procedure day)
measure: R0 and curative resection rates
timeFrame: Day 1 (procedure day)
measure: Total procedure time
timeFrame: Day 1 (procedure day)
measure: NASA Task Load Index
timeFrame: Day 1 (procedure day)
measure: Intraprocedural adverse events
timeFrame: Day 1 (procedure day), up to 48 hours after procedure.
measure: Post-procedural adverse events
timeFrame: 1 month post-procedure
measure: Abdominal pain
timeFrame: 1 hour post-procedure, 24 hours post-procedure.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
citation: Tanaka S, Terasaki M, Kanao H, Oka S, Chayama K. Current status and future perspectives of endoscopic submucosal dissection for colorectal tumors. Dig Endosc. 2012 May;24 Suppl 1:73-9. doi: 10.1111/j.1443-1661.2012.01252.x.
citation: Othman MO, Jawaid SA, Rungta M, Sur N, Dhingra S. Double-balloon endolumenal intervention platform with flexible grasper to expedite colonic endoscopic submucosal dissection. VideoGIE. 2020 Dec 26;6(3):144-146. doi: 10.1016/j.vgie.2020.11.014. eCollection 2021 Mar. No abstract available.
citation: Nagata M. Usefulness of underwater endoscopic submucosal dissection in saline solution with a monopolar knife for colorectal tumors (with videos). Gastrointest Endosc. 2018 May;87(5):1345-1353. doi: 10.1016/j.gie.2017.11.032. Epub 2017 Dec 12.
citation: Hernandez A, Marya NB, Sawas T, Rajan E, Gades NM, Wong Kee Song LM, Abu Dayyeh BK, Buttar N, Storm AC. Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video). Endosc Int Open. 2021 Apr;9(4):E572-E577. doi: 10.1055/a-1370-9256. Epub 2021 Apr 12.
citation: Ge PS, Thompson CC, Jirapinyo P, Aihara H. Suture pulley countertraction method reduces procedure time and technical demand of endoscopic submucosal dissection among novice endoscopists learning endoscopic submucosal dissection: a prospective randomized ex vivo study. Gastrointest Endosc. 2019 Jan;89(1):177-184. doi: 10.1016/j.gie.2018.08.032. Epub 2018 Aug 25.
citation: Rieder E, Makris KI, Martinec DV, Swanstrom LL. The suture-pulley method for endolumenal triangulation in endoscopic submucosal dissection. Endoscopy. 2011;43 Suppl 2 UCTN:E319-20. doi: 10.1055/s-0030-1256774. Epub 2011 Oct 21. No abstract available.
citation: Burgess NG, Bassan MS, McLeod D, Williams SJ, Byth K, Bourke MJ. Deep mural injury and perforation after colonic endoscopic mucosal resection: a new classification and analysis of risk factors. Gut. 2017 Oct;66(10):1779-1789. doi: 10.1136/gutjnl-2015-309848. Epub 2016 Jul 27.