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

Cold snare endoscopic mucosal resection versus standard hot technique for large flat non-pedunculated colonic lesions: Results of the CS-EMR 2019 randomized controlled trial

1   Department of Gastroenterology and Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain (Ringgold ID: RIN16483)
,
Carlos Carbonell-Blanco
1   Department of Gastroenterology and Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain (Ringgold ID: RIN16483)
,
2   Gastrointestinal Endoscopy Research Unit, Navarrobiomed, Pamplona, Spain (Ringgold ID: RIN561036)
3   Gastrointestinal Endoscopy Research Unit, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain
4   Gastrointestinal Endoscopy Research Unit, IdiSNA, Pamplona, Spain (Ringgold ID: RIN540940)
,
5   Gastroenterology Department, Hospital Clínic Barcelona, Barcelona, Spain
6   Gastroenterology, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
7   Universitat de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain
,
Juan Martínez-Sempere
8   Endoscopy Unit, Hospital General Universitario Dr Balmis, Alicante, Spain (Ringgold ID: RIN16802)
9   Gastroenterology, Instituto de Investigación Sanitaria y Biomédica de Alicante, ISABIAL, Alicante, Spain
,
10   Department of Gastroenterology, Hospital del Mar Medical Research Institute, Barcelona, Spain (Ringgold ID: RIN16551)
,
8   Endoscopy Unit, Hospital General Universitario Dr Balmis, Alicante, Spain (Ringgold ID: RIN16802)
9   Gastroenterology, Instituto de Investigación Sanitaria y Biomédica de Alicante, ISABIAL, Alicante, Spain
,
11   Department of Gastroenterology, Hospital Clinic de Barcelona, Barcelona, Spain (Ringgold ID: RIN16493)
,
12   Department of Digestive Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, Spain (Ringgold ID: RIN16514)
,
Javier Aranda Hernández
1   Department of Gastroenterology and Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain (Ringgold ID: RIN16483)
,
Alberto Alvarez Delgado
13   Department of Digestive Diseases, Hospital Universitario de Salamanca, Salamanca, Spain
,
14   Department of Gastroenterology and Hepatology, Hospital University Ramón y Cajal, Madrid, Spain
15   CIBEREHD, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain
,
16   Department of Digestive Diseases, Hospital Universitario Puerta de Hierro-Majadahonda, IDIPHISA. Universidad Autónoma de Madrid, Majadahonda, Spain
,
Angel Cañete Ruiz
17   Department of Digestive Diseases, Clínica Rotger Quirónsalud, Palma de Mallorca, Spain
,
Pablo Miranda Garcia
18   Department of Digestive Diseases, Hospital Universitario de la Princesa, Madrid, Spain (Ringgold ID: RIN16517)
,
19   Department of Digestive Diseases, Hospital Universitario Río Hortega, Valladolid, Spain (Ringgold ID: RIN16918)
,
Alberto Herreros de Tejada
16   Department of Digestive Diseases, Hospital Universitario Puerta de Hierro-Majadahonda, IDIPHISA. Universidad Autónoma de Madrid, Majadahonda, Spain
,
Eduardo Valdivielso Cortázar
20   Department of Digestive Diseases, Complexo Hospitalario Universitario A Coruña, A Coruna, Spain (Ringgold ID: RIN16811)
,
Pedro De María
21   Department of Digestive Diseases, Hospital University of La Paz, Madrid, Spain
,
David Busquets
22   Department of Digestive Diseases, Hospital Universitari Doctor Josep Trueta de Girona, Girona, Spain
,
Alfonso Elosua
23   Digestive Diseases Unit. Internal Medicine Department, Hospital García Orcoyen, Estella, Spain (Ringgold ID: RIN59533)
24   Gastroenterology, IdiSNA, Navarra Institute for Health Research, Pamplona, Spain
,
25   Gastroenterology Department, Hospital Clinic de Barcelona, Barcelona, Spain (Ringgold ID: RIN16493)
26   Gastroenterology, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
,
1   Department of Gastroenterology and Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain (Ringgold ID: RIN16483)
,
10   Department of Gastroenterology, Hospital del Mar Medical Research Institute, Barcelona, Spain (Ringgold ID: RIN16551)
,
27   Endoscopy Unit, Gastroenterology Department, Hospital Universitario de Navarra (HUN), Pamplona, Spain
28   Navarra Institute for Health Research, Navarrabiomed; Universidad Pública de Navarra (UPNA); IdiSNA, Pamplona, Spain
› Author Affiliations
Supported by: SEED Grant for working Groups
Supported by: Olympus Provided snares for the study

Clinical Trial: Registration number (trial ID): NCT04418843, Trial registry: ClinicalTrials.gov (http://www.clinicaltrials.gov/), Type of Study: Prospective, Randomized, Multi-Center Study

Backgrounds and Aims: Cold snare EMR (CS-EMR) in large flat non-pedunculated colonic lesions (LFNPCLs) is an alternative to the standard EMR procedure with a better safety profile, but scientific evidence on its efficacy is unavailable. Primary objective: To compare the recurrence rate between the two techniques at six months. Secondary objectives: comparison of the safety profile and several procedure-related outcomes. Patients and methods: This was a noninferiority, multicentric, open-label, randomized controlled trial of consecutive large (>20 mm) LFNPCLs without suspicious features of submucosal invasion. Results: A total of 229 patients were randomized to receive CS-EMR (n=115) or EMR (n=114), with adenomas (76.4%) and a median size of 25 mm. The trial was stopped early by clinical consensus according to a safety monitoring board. At first surveillance colonoscopy (n=220) the recurrence rate (RR) 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 ITT and PP analyses, respectively. According to the subgroup analysis, the RR was significantly greater for LFNPCLs >30 mm (18.2% EMR vs. 43.1% CS-EMR). There was no difference in the rate of adverse events. The use of clips was more common in the EMR group (2.21 vs. 1.30). Conclusions: Compared with the conventional hot technique, the RR of LFNPCL after CS-EMR was significantly greater. A similar safety profile was found between groups.



Publication History

Received: 31 July 2024

Accepted after revision: 19 February 2025

Accepted Manuscript online:
19 February 2025

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