Takeshi Yamashina1, Noriya Uedo2, Tomofumi Akasaka3, Taro Iwatsubo4, Yasuki Nakatani5, Takuji Akamatsu5, Takuji Kawamura6, Yoji Takeuchi4, Shigehiko Fujii7, Toshihiro Kusaka7, Toshio Shimokawa8. 1. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan; Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan. 2. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan. Electronic address: noriya.uedo@gmail.com. 3. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan; Department of Gastroenterology and Hepatology, National Hospital Organization, Osaka National Hospital, Osaka, Japan. 4. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan. 5. Department of Gastroenterology and Hepatology, Japanese Red Cross Society Wakayama Medical Center, Wakayama, Japan. 6. Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan. 7. Department of Gastroenterology and Hepatology, Kyoto Katsura Hospital, Kyoto, Japan. 8. Department of Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.
Abstract
BACKGROUND & AIMS:Endoscopic mucosal resection (EMR) with submucosal injection is an established method for removing colorectal polyps, although the en bloc resection rate decreases when polyp size exceeds 10 mm. Piecemeal resection increases local recurrence. Underwater EMR (UEMR) is an effective technique for removal of sessile colorectal polyps and we investigated whether it is superior to conventional EMR (CEMR). METHODS: We conducted a multicenter randomized controlled trial at 5 institutions in Japan. Patients with endoscopically diagnosed, intermediate-size (10-20 mm) sessile colorectal lesions were randomly assigned to undergo UEMR or CEMR. Only the most proximal lesion was registered. The UEMR procedure included immersion of the entire lumen in water and snare resection of the lesion without submucosal injection of normal saline. We analyzed outcomes of 108 colorectal lesions in the UEMR group and 102 lesions in the CEMR group. R0 resection was defined as en bloc resection with a histologically confirmed negative resection margin. The primary endpoint was the difference in the R0 resection rates between groups. RESULTS: The proportions of R0 resections were 69% (95% confidence interval [CI] 59%-77%) in the UEMR group vs 50% (95% CI 40%-60%) in the CEMR group (P = .011). The proportions of en bloc resections were 89% (95% CI 81%-94%) in the UEMR group vs 75% (95% CI 65%-83%) in the CEMR group (P = .007). There was no significant difference in median procedure time (165 vs 175 seconds) or proportions of patients with adverse events (2.8% in the UEMR group vs 2.0% in the CEMR group). CONCLUSIONS: In a multicenter randomized controlled trial, we found that UEMR significantly increased the proportions of R0 resections for 10- to 20-mm sessile colorectal lesions without increasing adverse events or procedure time. Use of this procedure should be encouraged. Trials registry number: UMIN000018989.
RCT Entities:
BACKGROUND & AIMS: Endoscopic mucosal resection (EMR) with submucosal injection is an established method for removing colorectal polyps, although the en bloc resection rate decreases when polyp size exceeds 10 mm. Piecemeal resection increases local recurrence. Underwater EMR (UEMR) is an effective technique for removal of sessile colorectal polyps and we investigated whether it is superior to conventional EMR (CEMR). METHODS: We conducted a multicenter randomized controlled trial at 5 institutions in Japan. Patients with endoscopically diagnosed, intermediate-size (10-20 mm) sessile colorectal lesions were randomly assigned to undergo UEMR or CEMR. Only the most proximal lesion was registered. The UEMR procedure included immersion of the entire lumen in water and snare resection of the lesion without submucosal injection of normal saline. We analyzed outcomes of 108 colorectal lesions in the UEMR group and 102 lesions in the CEMR group. R0 resection was defined as en bloc resection with a histologically confirmed negative resection margin. The primary endpoint was the difference in the R0 resection rates between groups. RESULTS: The proportions of R0 resections were 69% (95% confidence interval [CI] 59%-77%) in the UEMR group vs 50% (95% CI 40%-60%) in the CEMR group (P = .011). The proportions of en bloc resections were 89% (95% CI 81%-94%) in the UEMR group vs 75% (95% CI 65%-83%) in the CEMR group (P = .007). There was no significant difference in median procedure time (165 vs 175 seconds) or proportions of patients with adverse events (2.8% in the UEMR group vs 2.0% in the CEMR group). CONCLUSIONS: In a multicenter randomized controlled trial, we found that UEMR significantly increased the proportions of R0 resections for 10- to 20-mm sessile colorectal lesions without increasing adverse events or procedure time. Use of this procedure should be encouraged. Trials registry number: UMIN000018989.
Authors: Tiing Leong Ang; Jit Fong Lim; Tju Siang Chua; Kok Yang Tan; James Weiquan Li; Chern Hao Chong; Kok Ann Gwee; Vikneswaran S/O Namasivayam; Charles Kien Fong Vu; Christopher Jen Lock Khor; Lai Mun Wang; Khay Guan Yeoh Journal: Singapore Med J Date: 2020-07-16 Impact factor: 3.331