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

Официальное название

Prospective Study Evaluating the Use of a Novel Through - the- Scope Suturing System as a Dynamic Traction Device During ESD: A Feasibility Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Traction 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 o

Первичные конечные точки

• Technical success [Срок оценки: Day 1 (procedure day)]

Вторичные конечные точки (7)

• Dissection speed [Срок оценки: Day 1 (procedure day)]
• R0 and curative resection rates [Срок оценки: Day 1 (procedure day)]
• Total procedure time [Срок оценки: Day 1 (procedure day)]
• NASA Task Load Index [Срок оценки: Day 1 (procedure day)]
• Intraprocedural adverse events [Срок оценки: Day 1 (procedure day), up to 48 hours after procedure.]
• Post-procedural adverse events [Срок оценки: 1 month post-procedure]
• Abdominal pain [Срок оценки: 1 hour post-procedure, 24 hours post-procedure.]

Критерии участия

Критерии включения

• The patient is ≥ 18 years old.
• Patients can provide informed consent.
• 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.

Критерии исключения

• The patient is < 18 years old.
• The patient refuses and/or is unable to provide consent.
• The patient is a pregnant woman.
• Lesions with morphology: pedunculated type (Paris Ip, Ips).
• Appendiceal orifice or IC valve lesions
• Patients with lesions removed with other techniques besides ESD (submucosal tunneling technique \[STER\] or EMR).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Baylor College of Medicine — Houston

Публикации

• 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. PMID 22533757
• 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. PMID 33738368
• 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. PMID 29242059
• 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. PMID 33860074
• 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. PMID 30148993
• 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. PMID 22020705
• 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. PMID 27464708

Идентификаторы

NCT: NCT06747988 · H-56820

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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