Endoscopy 2025; 57(08): 851-861
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

Authors

  • Oscar Nogales

    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
  • Sheyla Montori Pina

    2   Gastroenterology Research Unit, Navarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Navarra Institute for Health Research, Pamplona, Spain
  • María Pellisé

    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
  • Fausto Riu Pons

    5   Department of Gastroenterology, Hospital del Mar Research Institute, Barcelona, Spain
  • Carolina Mangas-Sanjuan

    4   Endoscopy Unit, Hospital General Universitario Dr. Balmis, Instituto de Investigación Sanitaria y Biomédica de Alicante, ISABIAL, Alicante, Spain
  • María Daca-Alvarez

    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
  • Hugo Uchima

    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
  • Enrique Rodríguez de Santiago

     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
  • Jose Santiago García

     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
  • Henar Núñez Rodriguez

    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
  • Liseth Rivero-Sánchez

    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
  • María López-Ibáñez

    1   Department of Gastroenterology and Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain
  • Marco A. Alvarez-Gonzalez

    5   Department of Gastroenterology, Hospital del Mar Research Institute, Barcelona, Spain
  • Eduardo Albéniz

    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

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


Graphical Abstract

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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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