Cold snare endoscopic mucosal resection versus standard hot technique for large flat nonpedunculated colonic lesions: a randomized controlled trial
Óscar Nogales, Carlos Carbonell-Blanco, Sheyla Montori, María Pellisé, Juan Martínez-Sempere, Faust Riu, Carolina Mangas‐Sanjuán, María Daca-Álvarez, Hugo Uchima, Javier Aranda Hernández, Alberto Álvarez Delgado, Enrique Rodríguez de Santiago, José Santiago García, Ángel Cañete Ruiz, Pablo Miranda García, Henar Núñez, Alberto Herreros de Tejada, Eduardo Valdivielso Cortázar, Pedro De María, David Busquets, Alfonso Elosua, Liseth Rivero, María López-Ibáñez, Marco Antonio Álvarez, Eduardo Albéniz, on behalf of the Mucosal Resection and Third-Space Endoscopy SEED Working Group
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.