Endoscopy
DOI: 10.1055/a-2542-9759
Original article

Cold snare endoscopic mucosal resection versus standard hot technique for large flat nonpedunculated colonic lesions: a randomized controlled trial

1   Department of Gastroenterology and Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain
,
Carlos Carbonell Blanco
1   Department of Gastroenterology and Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain
,
2   Gastroenterology Research Unit, Navarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Navarra Institute for Health Research, Pamplona, Spain
,
3   Gastroenterology Department, Hospital Clínic de Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Universitat de Barcelona, Barcelona, Spain
,
Juan F. Martínez Sempere
4   Endoscopy Unit, Hospital General Universitario Dr. Balmis, Instituto de Investigación Sanitaria y Biomédica de Alicante, ISABIAL, Alicante, Spain
,
5   Department of Gastroenterology, Hospital del Mar Research Institute, Barcelona, Spain
,
4   Endoscopy Unit, Hospital General Universitario Dr. Balmis, Instituto de Investigación Sanitaria y Biomédica de Alicante, ISABIAL, Alicante, Spain
,
3   Gastroenterology Department, Hospital Clínic de Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Universitat de Barcelona, Barcelona, Spain
,
6   Department of Digestive Diseases, Hospital Universitario Germans Trias i Pujol, Badalona, Spain
,
Javier Aranda-Hernández
1   Department of Gastroenterology and Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain
,
Alberto Alvarez Delgado
 7   Department of Digestive Diseases, Hospital Universitario de Salamanca, Salamanca, Spain
,
 8   Department of Gastroenterology and Hepatology, Hospital University Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), CIBEREHD, Universidad de Alcalá, Madrid, Spain
,
 9   Department of Digestive Diseases, Hospital Universitario Puerta de Hierro-Majadahonda, IDIPHISA, Universidad Autónoma de Madrid, Majadahonda, Madrid, Spain
,
Ángel Cañete Ruiz
10   Department of Digestive Diseases, Clínica Rotger Quirónsalud, Palma de Mallorca, Spain
,
Pablo Miranda García
11   Department of Digestive Diseases, Hospital Universitario de La Princesa, Madrid, Spain
,
12   Department of Digestive Diseases, Hospital Universitario Río Hortega, Valladolid, Spain
,
Alberto Herreros-de-Tejada
 9   Department of Digestive Diseases, Hospital Universitario Puerta de Hierro-Majadahonda, IDIPHISA, Universidad Autónoma de Madrid, Majadahonda, Madrid, Spain
,
Eduardo Valdivielso Cortazar
13   Department of Digestive Diseases, Complexo Hospitalario Universitario A Coruña, A Coruña, Spain
,
Pedro De María
14   Department of Digestive Diseases, Hospital University of La Paz, Madrid, Spain
,
David Busquets
15   Department of Digestive Diseases, Hospital Universitari Doctor Josep Trueta de Girona, Girona, Spain
,
Alfonso Elosua
16   Digestive Diseases Unit, Internal Medicine Department, Hospital García Orcoyen, Estella, Spain
17   IdiSNA, Navarra Institute for Health Research, Pamplona, Spain
,
3   Gastroenterology Department, Hospital Clínic de Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Universitat de Barcelona, Barcelona, Spain
,
1   Department of Gastroenterology and Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain
,
5   Department of Gastroenterology, Hospital del Mar Research Institute, Barcelona, Spain
,
18   Endoscopy Unit, Gastroenterology Department, Hospital Universitario de Navarra (HUN), Navarrabiomed, Universidad Pública de Navarra (UPNA), IdiSNA, Navarra Institute for Health Research, Pamplona, Spain
,
on behalf of the Mucosal Resection and Third-Space Endoscopy SEED Working Group› Author Affiliations

SEED Grant for working Groups Olympus Provided snares for the studyTrial Registration: ClinicalTrials.gov Registration number (trial ID): NCT04418843 Type of study: Prospective, Randomized, Multi-Center Study


Preview

Abstract

Backgrounds Cold snare EMR (CS-EMR) in large flat nonpedunculated colonic lesions (LFNPCLs) is an alternative to the standard EMR procedure with a better safety profile, but scientific evidence on its efficacy is unavailable. This study aimed to compare the recurrence rate between the two techniques at 6 months. Secondary aims were comparison of the safety profile and procedure-related outcomes.

Methods This was a noninferiority, multicenter, open-label, randomized controlled trial of consecutive large (≥ 20 mm) LFNPCLs without suspicious features of submucosal invasion.

Results 229 patients were randomized to receive CS-EMR (n = 115) or EMR (n = 114). The median lesion size was 25 mm and 74.6 % were adenomas. The trial was stopped early by clinical consensus according to a safety monitoring board. At first surveillance colonoscopy (n = 220) the recurrence rate was significantly greater in the CS-EMR group than in the EMR group: 33.0 % vs. 16.2 % (P = 0.004) and 34.7 % vs. 14.8 % (P = 0.001) in the intention-to-treat and per-protocol analyses, respectively. According to the subgroup analysis, the recurrence rate was significantly greater after CS-EMR for LFNPCLs ≥ 30 mm (43.1 % vs. 18.2 %). There was no difference in the rate of adverse events. The use of clips was more common in the EMR group (52.6 % vs. 27.8 %).

Conclusions The recurrence rate of LFNPCLs after CS-EMR was significantly greater than after the standard hot technique. A similar safety profile was found between groups.

Supplementary Material



Publication History

Received: 31 July 2024

Accepted after revision: 19 February 2025

Accepted Manuscript online:
19 February 2025

Article published online:
15 April 2025

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