Underwater versus conventional EMR of large nonpedunculated colorectal lesions: a multicenter randomized controlled trial.


Journal

Gastrointestinal endoscopy
ISSN: 1097-6779
Titre abrégé: Gastrointest Endosc
Pays: United States
ID NLM: 0010505

Informations de publication

Date de publication:
05 2023
Historique:
received: 26 10 2022
revised: 23 11 2022
accepted: 17 12 2022
medline: 21 4 2023
pubmed: 27 12 2022
entrez: 26 12 2022
Statut: ppublish

Résumé

Underwater EMR (UEMR) is an alternative procedure to conventional EMR (CEMR) to treat large, nonpedunculated colorectal lesions (LNPCLs). In this multicenter, randomized controlled clinical trial, we aimed to compare the efficacy and safety of UEMR versus CEMR on LNPCLs. We conducted a multicenter, randomized controlled clinical trial from February 2018 to February 2020 in 11 hospitals in Spain. A total of 298 patients (311 lesions) were randomized to the UEMR (n = 149) and CEMR (n = 162) groups. The main outcome was the lesion recurrence rate in at least 1 follow-up colonoscopy. Secondary outcomes included technical aspects, en bloc resection rate, R0 resection rates, and adverse events, among others. There were no differences in the overall recurrence rate (9.5% UEMR vs 11.7% CEMR; absolute risk difference, -2.2%; 95% CI, -9.4 to 4.9). However, considering polyp sizes between 20 and 30 mm, the recurrence rate was lower for UEMR (3.4% UEMR vs 13.1% CEMR; absolute risk difference, -9.7%; 95% CI, -19.4 to 0). The R0 resection showed the same tendency, with significant differences favoring UEMR only for polyps between 20 and 30 mm. Overall, UEMR was faster and easier to perform than CEMR. Importantly, the techniques were equally safe. UEMR is a valid alternative to CEMR for treating LNPCLs and could be considered the first option of treatment for lesions between 20 and 30 mm due to its higher en bloc and R0 resection rates. (Clinical trial registration number: NCT03567746.).

Sections du résumé

BACKGROUND AND AIMS
Underwater EMR (UEMR) is an alternative procedure to conventional EMR (CEMR) to treat large, nonpedunculated colorectal lesions (LNPCLs). In this multicenter, randomized controlled clinical trial, we aimed to compare the efficacy and safety of UEMR versus CEMR on LNPCLs.
METHODS
We conducted a multicenter, randomized controlled clinical trial from February 2018 to February 2020 in 11 hospitals in Spain. A total of 298 patients (311 lesions) were randomized to the UEMR (n = 149) and CEMR (n = 162) groups. The main outcome was the lesion recurrence rate in at least 1 follow-up colonoscopy. Secondary outcomes included technical aspects, en bloc resection rate, R0 resection rates, and adverse events, among others.
RESULTS
There were no differences in the overall recurrence rate (9.5% UEMR vs 11.7% CEMR; absolute risk difference, -2.2%; 95% CI, -9.4 to 4.9). However, considering polyp sizes between 20 and 30 mm, the recurrence rate was lower for UEMR (3.4% UEMR vs 13.1% CEMR; absolute risk difference, -9.7%; 95% CI, -19.4 to 0). The R0 resection showed the same tendency, with significant differences favoring UEMR only for polyps between 20 and 30 mm. Overall, UEMR was faster and easier to perform than CEMR. Importantly, the techniques were equally safe.
CONCLUSIONS
UEMR is a valid alternative to CEMR for treating LNPCLs and could be considered the first option of treatment for lesions between 20 and 30 mm due to its higher en bloc and R0 resection rates. (Clinical trial registration number: NCT03567746.).

Identifiants

pubmed: 36572129
pii: S0016-5107(22)02223-4
doi: 10.1016/j.gie.2022.12.013
pii:
doi:

Substances chimiques

Water 059QF0KO0R

Banques de données

ClinicalTrials.gov
['NCT03567746']

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

941-951.e2

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Auteurs

Joaquín Rodríguez Sánchez (J)

Endoscopy Unit, Hospital Universitario 12 de Octubre de Madrid, Madrid, Spain; Hospital General Universitario de Ciudad Real, Ciudad Real, Spain. Electronic address: joakinrodriguez@gmail.com.

Marco A Alvarez-Gonzalez (MA)

Department of Digestive Diseases, Hospital del Mar, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Barcelona, Spain.

María Pellisé (M)

Gastroenterology Department, Hospital Clínic de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain.

David Coto-Ugarte (D)

Cruces University Hospital Endoscopy Unit Barakaldo, Basque Country, Spain.

Hugo Uchima (H)

Endoscopy Unit, Department of Gastroenterology, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.

Javier Aranda-Hernández (J)

Endoscopy Unit, Department of Gastroenterology & Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.

José Santiago García (J)

Gastroenterology Department, Research Institute Segovia de Arana, Puerta de Hierro University Hospital, Autonomous University of Madrid, Madrid, Spain.

José Carlos Marín-Gabriel (JC)

Endoscopy Unit, Gastroenterology Department, "i+12 Research Institute," Hospital Universitario 12 de Octubre, Universidad Complutense, Madrid, Spain.

Fausto Riu Pons (F)

Gastroenterology Department, Endoscopy Unit, Hospital del Mar, Parc de Salut Mar, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.

Oscar Nogales (O)

Endoscopy Unit, Department of Gastroenterology & Hepatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.

Ramiro Carreño Macian (R)

Department of Gastroenterology, Hospital San Pedro, Logroño, Spain.

Alberto Herreros-de-Tejada (A)

Gastroenterology Department, Research Institute Segovia de Arana, Puerta de Hierro University Hospital, Autonomous University of Madrid, Madrid, Spain.

Luis Hernández (L)

Hospital Santos Reyes, Aranda de Duero, Burgos, Spain.

G Oliver Patrón (GO)

Hospital Manacor and Hospital Parque Llevant, Palma de Mallorca, Spain.

Manuel Rodriguez-Tellez (M)

Digestive Diseases, Virgen Macarena University Hospital, Sevilla, Spain.

Eduardo Redondo-Cerezo (E)

Endoscopy Unit, Department of Gastroenterology and Hepatology, "Virgen de Las Nieves" University Hospital, Granada, Spain.

Mónica Sánchez Alonso (M)

Servicio de Aparato Digestivo, Hospital Santa Bárbara, Puertollano, Spain.

Maria Daca (M)

Gastroenterology Department, Hospital Clínic de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain.

Eduardo Valdivielso-Cortazar (E)

Department of Gastroenterology, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.

Alberto Álvarez Delgado (A)

Gastroenterologist Department, Salamanca University Hospital, Salamanca, Spain.

Mónica Enguita (M)

Methodology Unit,. Navarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.

Sheyla Montori (S)

Gastrointestinal Endoscopy Research Unit, Navarrabiomed, Hospital Universitario de Navarra (HUN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.

Eduardo Albéniz (E)

Endoscopy Unit, Gastroenterology Department, Hospital Universitario de Navarra (HUN), Navarrabiomed, Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain. Electronic address: edualbeniz@hotmail.com.

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