Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.

Официальное название

Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Laterally Spreading Lesions Non Granular-Flat Elevated Type (LSL-NG-FE) ≥ 20 mm and LSLs-Granular Mixed Type ≥ 30 mm. A Randomized, Non-inferiority Trial.

Обзор

EMR and ESD are both effective and safe and are associated with a very low risk of procedure related mortality when performed for colorectal laterally spreading lesions (LSL). Some kind of LSLs have a low risk of submucosal invasive carcinoma (SMIC) or these foci are found in well demarcated areas of the tumor. This is the case of the non-granular flat elevated (LSN-NG-FE) and the LSLs-G mixed subtypes. The investigators aim to assess if piecemeal EMR (the older technique) for LSLs-G mixed type \> 30 mm and LSLs-NG FE type \> 20 mm is not inferior to ESD (the new treatment) for the need of additional surgery in the mid-term.

Подробное описание

Endoscopic submucosal dissection (ESD) is curative for lesions with superficial submucosal invasive carcinoma (s-SMIC) and favourable histological features. The procedure is performed mainly for laterally spreading lesions (LSLs) and is the reference treatment for these neoplasms in Asian countries nowadays. LSLs can be granular (G) or non-granular (NG). Most LSLs-G homogenous type are superficial and can be resected by EMR because SMIC is often lacking. On the other hand, since LSLs-G mixed type \> 20 - 30 mm have a higher prevalence of SMIC when compared with the homogenous subtype, Asian experts now recommend ESD for this kind of tumors. However, some years ago, EMR had been suggested for LSLs-G mixed type if the largest nodule was resected first and the histological assessment was done separately. The rationale for the latter approach is that the invasive component is usually found within the large nodule.

Conversely, the prevalence of SMIC is higher in LSLs-NG PD type, therefore, ESD is the preferred therapeutic intervention. In addition, LSLs-NG FE type have been associated with multifocal invasion in Japanese studies. However, in Western countries, the percentage of SMIC in LSLs-NG FE type \> 20 mm seems much lower than previously described in Asian series. Thus, the investigators do not know if EMR might be enough to remove these tumours.

Furthermore, if the risk of s-SMIC is low, the recurrence rates for ESD in these kind of lesions (LSL-G mixed type \> 30 mm and LSL-NG FE type \> 20 mm) might be comparable to that of piecemeal EMR, in terms of curative resection (avoiding the need for surgery) in the mid-term. When performing an EMR, recurrences are more frequent, but they are largely inconsequential because it is usually unifocal, diminutive and easily can be managed endoscopically on subsequent sessions.

In order to clarify the controversial issue of performing colorectal ESD in Western countries, the investigators aim to assess if piecemeal EMR (the older technique) for LSLs-G mixed type \> 30 mm and LSLs-NG FE type \> 20 mm is not inferior to ESD (the new treatment) for the need of additional surgery in the mid-term.

Вмешательства

• Процедура Endoscopic mucosal resection (EMR)
  Endoscopic mucosal resection (EMR) is an endoscopic resection technique that allows the removal of large colorectal lesions using a conventional "lift-and-cut" procedure or an underwater technique
• Процедура Endoscopic submucosal dissection (ESD)
  Endoscopic submucosal dissection (ESD) is an endoscopic procedure that allows dissection of larger colorectal lesions in one piece using endoknives. The procedure is technically more difficult, much more time-consuming than EMR, mandates multiday hospital admission and has an increased risk of perforation.

Первичные конечные точки

• Percentage of surgical referral after treatment [Срок оценки: Month 18]

Вторичные конечные точки (6)

• En bloc resection rate [Срок оценки: Month 1]
• R0 resection rate [Срок оценки: Month 1]
• Duration of the procedure [Срок оценки: Month 1]
• Percentage of curative resection rates without surgery [Срок оценки: Month 18]
• Proportion of cases in which the endoscopist has to change technique to the alternative procedure [Срок оценки: Month 1]
• Cumulative complications rate after treatment [Срок оценки: Month 1 and 18]

Критерии участия

Критерии включения

• Adults (at least 18 years old).
• LSL-NG FE type ≥ 20mm or LST-G mixed type ≥30mm who have not been previously treated or received submucosal injection, regardless of their location in the colon.
• LSL-NG FE type ≥ 20mm or LST-G mixed type ≥30mm WITHOUT a demarcated area
• The patient must have undergone a complete colonoscopy, reaching the cecum, to detect possible synchronous lesion. If this procedure has not been done previously, it will be performed prior to the inclusion of the patient in the study.
• Patients able to fill in questionnaires written in Spanish or English.

Критерии исключения

• Contra-indication to colonoscopy.
• Contra-indication to general anesthesia.
• Inability to stop antiplatelet agents and anti-coagulant according to the European Society of Gastro-Intestinal Endoscopy guidelines.
• Patients with > 1 lesion meeting the inclusion criteria.
• LSL-NG FE type ≥ 20mm or LST-G ≥30mm mixed type that have been previously treated (Recurrence or residual lesion after previous endoscopic or surgical treatment).
• LSL-NG FE type ≥ 20mm or LST-G ≥30mm mixed type with previous submucosal injection, even if a resection attempt with a snare was not finally performed.
• Lesions with suspicion of deep submucosal invasive carcinoma: depression or invasive pit-pattern (Vi within a demarcated area or Vn).
• Submucosal mass like elevation within a LSL-NG FE type.
• LSLs having a previous biopsy or tattooing. Previous biopsies of the lesion should only be allowed if LSL-G mixed type > 30 mm and samples were taken out of the flat area.
• LSL-G with a Buddha like deformation (Polyp on polyp)
• LSL involving a surgical anastomosis.
• LSL involving the appendicular orifice.
• LSL involving the terminal ileum.
• Patient's refusal to participate in the study
• Presence of inflammatory bowel disease
• Pregnant or lactating women.
• Hereditary colorectal cancer syndrome or hereditary polyposis.
• Patient under legal protection and or deprived of liberty by judicial or administrative decision.
• Patient already participating in an interventional clinical research protocol
• Patient who cannot be followed for the duration of the study.
• Inability to sign the informed consent of the study.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario "12 de Octubre" — Madrid

Публикации

• Burgess NG, Hourigan LF, Zanati SA, Brown GJ, Singh R, Williams SJ, Raftopoulos SC, Ormonde D, Moss A, Byth K, Mahajan H, McLeod D, Bourke MJ. Risk Stratification for Covert Invasive Cancer Among Patients Referred for Colonic Endoscopic Mucosal Resection: A Large Multicenter Cohort. Gastroenterology. 2017 Sep;153(3):732-742.e1. doi: 10.1053/j.gastro.2017.05.047. Epub 2017 Jun 2. PMID 28583826
• Uraoka T, Saito Y, Matsuda T, Ikehara H, Gotoda T, Saito D, Fujii T. Endoscopic indications for endoscopic mucosal resection of laterally spreading tumours in the colorectum. Gut. 2006 Nov;55(11):1592-7. doi: 10.1136/gut.2005.087452. Epub 2006 May 8. PMID 16682427
• Moss A, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Burgess NG, Sonson R, Byth K, Bourke MJ. Long-term adenoma recurrence following wide-field endoscopic mucosal resection (WF-EMR) for advanced colonic mucosal neoplasia is infrequent: results and risk factors in 1000 cases from the Australian Colonic EMR (ACE) study. Gut. 2015 Jan;64(1):57-65. doi: 10.1136/gutjnl-2013-305516. Epub PMID 24986245
• Albeniz E, Pellise M, Gimeno-Garcia AZ, Lucendo AJ, Alonso-Aguirre PA, Herreros de Tejada A, Alvarez MA, Fraile M, Herraiz Bayod M, Lopez Roses L, Martinez Ares D, Ono A, Parra Blanco A, Redondo E, Sanchez-Yague A, Soto S, Diaz-Tasende J, Montes Diaz M, Rodriguez-Tellez M, Garcia O, Zuniga Ripa A, Hernandez Conde M, Alberca de Las Parras F, Gargallo CJ, Saperas E, Munoz Navas M, Gordillo J, Ramos PMID 29421912
• Yang D, Othman M, Draganov PV. Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection For Barrett's Esophagus and Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2019 May;17(6):1019-1028. doi: 10.1016/j.cgh.2018.09.030. Epub 2018 Sep 26. PMID 30267866
• Fujiya M, Tanaka K, Dokoshi T, Tominaga M, Ueno N, Inaba Y, Ito T, Moriichi K, Kohgo Y. Efficacy and adverse events of EMR and endoscopic submucosal dissection for the treatment of colon neoplasms: a meta-analysis of studies comparing EMR and endoscopic submucosal dissection. Gastrointest Endosc. 2015 Mar;81(3):583-95. doi: 10.1016/j.gie.2014.07.034. Epub 2015 Jan 13. PMID 25592748
• Arezzo A, Passera R, Marchese N, Galloro G, Manta R, Cirocchi R. Systematic review and meta-analysis of endoscopic submucosal dissection vs endoscopic mucosal resection for colorectal lesions. United European Gastroenterol J. 2016 Feb;4(1):18-29. doi: 10.1177/2050640615585470. Epub 2015 May 5. PMID 26966519
• Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8. PMID 21392504

Идентификаторы

NCT: NCT04593407 · intERsection-19/281

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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