Traction vs. No Traction in Colonic ESD

Официальное название

Comparison of the Efficacy of Using a Traction Device in Colonic Endoscopic Submucosal Dissection Versus Conventional ESD: A Randomized Clinical Trial

Обзор

The goal of this prospective, randomized, controlled trial conducted at Baylor St. Luke's Medical Center is to compare the effectiveness and clinical outcomes of using a traction device in colonic endoscopic submucosal dissection (ESD) to those of using conventional ESD. The investigators of this study hypothesize that use of the traction device will help expedite colonic endoscopic submucosal dissections.

Подробное описание

Endoscopic submucosal dissection (ESD) is the mainstay for the treatment of complex colorectal polyps particularly those with a higher risk of superficial submucosal invasion. However, colonic ESD is technically difficult given the thin colon wall and difficult locations of lesion. Endoscopic submucosal dissection (ESD) of colonic lesions can be difficult because the thins wall of the colon wall and the lack of submucosal space expansion to the degree seen in the submucosal dissection in the esophagus or the stomach. ESD can be done in a standard fashion with circumferential incision followed by submucosal dissection according to gravity, tunneling methods, pocket methods or traction. Traction is frequently used to expedite submucosal dissection in particularly in tough locations or in fibrotic lesions. Traction assisted ESD is particularly attractive in colonic ESD given the above-mentioned difficulties and the challenge with performing other techniques such as tunneling or pocket formation in fibrotic lesions or lesions over folds. Tissue traction can be applied by several methods including gravity, mucosal tension, water pressure, and adjusting the patient's body position. Traction can also be applied using devices such as clip and line, snare or using additional endoscope. Data regarding the value of traction in colonic ESD is controversial. Despite multiple publications about the efficacy of traction devices in the east, there are few published data from the west. The Sure trac system was recently approved in the US for traction assisted ESD. The system has 2 devices, the primary device comes preloaded with a silicone band, while the secondary device features a clip of the same size as the primary device to apply traction on the opposite wall. Traction with sure trac system, is readily assembled and easily accessible and it is equipped with its own clip for swift implementation, thus expediting the process. The purpose of this research is to compare the effectiveness and safety of the sure trac traction system (Micro Tec endoscopy, USA) to standard ESD without applying traction.

Вмешательства

• Процедура Endoscopic Submucosal Dissection
  Endoscopic submucosal dissection (ESD) will be the technique used to remove target lesions.
• Устройство Traction Device
  Use of traction device to aid in removing target lesions

Первичные конечные точки

• Dissection speed [Срок оценки: Day 1 (procedure day)]

Вторичные конечные точки (5)

• En-bloc, R0, and curative resection rates [Срок оценки: Day 1 (procedure day)]
• Total procedure time [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

• Patient is ≥ 18 years old.
• Patients can provide informed consent.
• Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria:

A- Lesions with prior resection or with scar at any size. B- Granular lateral spreading tumors (GLST) more than 3 cm. C- Non granular lateral spreading tumors (NGLST) more than 20 mm. D- Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign.

Критерии исключения

• Patient is < 18 years old.
• Patient refused and/or unable to provide consent.
• Patient is a pregnant woman.
• Lesions with morphology: pedunculated type (Paris IP, Ips).
• Appendiceal orifice or IC valve lesions. 6. Patients with lesions removed with other techniques besides ESD (like hybrid ESD or submucosal tunneling technique STER and EMR).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 2 центра

• Baylor College of Medicine — Houston
• Baylor St. Lukes Medical Center (BSLMC) — 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
• Tamaru Y, Kuwai T, Miyakawa A, Kanazawa N, Kusunoki R, Shimura H, Uchiyama S, Ishaq S, Kohno H. Efficacy of a Traction Device for Endoscopic Submucosal Dissection Using a Scissor-Type Knife: A Randomized Controlled Trial. Am J Gastroenterol. 2022 Nov 1;117(11):1797-1804. doi: 10.14309/ajg.0000000000002019. Epub 2022 Sep 26. PMID 36191269
• 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
• Yamasaki Y, Takeuchi Y, Uedo N, Kato M, Hamada K, Aoi K, Tonai Y, Matsuura N, Kanesaka T, Yamashina T, Akasaka T, Hanaoka N, Higashino K, Ishihara R, Iishi H. Traction-assisted colonic endoscopic submucosal dissection using clip and line: a feasibility study. Endosc Int Open. 2016 Jan;4(1):E51-5. doi: 10.1055/s-0041-107779. Epub 2015 Nov 30. PMID 26793785
• 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: NCT06159634 · H-53522

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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