TY - JOUR
T1 - Nonrecurrence Rate of Underwater EMR for ≤20-mm Nonampullary Duodenal Adenomas
T2 - A Multicenter Prospective Study (D-UEMR Study)
AU - D-UEMR Study Group
AU - Yamasaki, Yasushi
AU - Uedo, Noriya
AU - Akamatsu, Takuji
AU - Kagawa, Tomo
AU - Higashi, Reiji
AU - Dohi, Osamu
AU - Furukawa, Masanori
AU - Takahashi, Yu
AU - Inoue, Takuya
AU - Tanaka, Shouichi
AU - Takenaka, Ryuta
AU - Iguchi, Mikitaka
AU - Kawamura, Takuji
AU - Tsuzuki, Takao
AU - Yamasaki, Tomoaki
AU - Yamashina, Takeshi
AU - Nasu, Junichiro
AU - Mannami, Tomohiko
AU - Yamauchi, Atsushi
AU - Matsueda, Kazuhiro
AU - Aizawa, Shigeyuki
AU - Mitsuhashi, Toshiharu
AU - Okada, Hiroyuki
AU - Kanzaki, Hiromitsu
AU - Inoue, Shuntaro
AU - Miyake, Muneaki
AU - Ohmori, Masayasu
AU - Takeuchi, Yoji
AU - Tani, Yasuhiro
AU - Harada, Nobuyuki
AU - Agatsuma, Nobukazu
AU - Okada, Keijirou
AU - Ikenouchi, Maiko
AU - Nakatani, Yasuki
AU - Uenoyama, Yoshito
AU - Yamashita, Yukitaka
AU - Ishikawa, Shigenao
AU - Inaba, Tomoki
AU - Miyahara, Koji
AU - Moritou, Yuki
AU - Nakagawa, Masahiro
AU - Kitae, Hiroaki
AU - Ishida, Tsugitaka
AU - Naito, Yuji
AU - Nishio, Akiyoshi
AU - Shimatani, Masaaki
AU - Kato, Ryo
AU - Taki, Shinya
AU - Mandai, Koichiro
AU - Sanada, Kasumi
N1 - Funding Information:
The authors thank Ms. Hiromi Kuramoto, Ms. Masumi Yamamoto, and Ms. Toshie Ishii (research assistants) for data management, the members of the D-UEMR Study Group (listed in nonauthor members of the D-UEMR Study Group) for their participation, the members of the Efficacy and Safety Assessment Committee (Dr Atsushi Imagawa, Imagawa Medical Clinic; Dr Motohiko Kato, Keio University; and Dr Masao Yoshida, Shizuoka Cancer Center) for their contribution, the members of the Endoscopic Device Selection Conference in Kansai (Chairperson, Prof. Masayuki Kitano, Wakayama Medical University) for their support, and the members of the Okayama GUT Study Group (Chairperson, Prof. Hiroyuki Okada) for their support. The authors thank Cathel Kerr, BSc, PhD, from Edanz Group (https://en-author-services.edanz.com/ac) for editing a draft of this manuscript. Nonauthor members of the D-UEMR Study Group: Okayama University Hospital: Hiromitsu Kanzaki; Osaka International Cancer Institute: Shuntaro Inoue, Muneaki Miyake, Masayasu Ohmori and Yoji Takeuchi; Japanese Red Cross Society Wakayama Medical Center: Yasuhiro Tani, Nobuyuki Harada, Nobukazu Agatsuma, Keijirou Okada, Maiko Ikenouchi, Yasuki Nakatani, Yoshito Uenoyama and Yukitaka Yamashita; Kagawa Prefectural Central Hospital: Shigenao Ishikawa, Tomoki Inaba; Hiroshima City Hiroshima Citizens Hospital: Koji Miyahara, Yuki Moritou and Masahiro Nakagawa; Kyoto Prefectural University of Medicine: Hiroaki Kitae, Tsugitaka Ishida, Yuji Naito; Nara Medical University Hospital: none; Kansai Medical University: Akiyoshi Nishio, Masaaki Shimatani; Osaka General Medical Center: none; National Hospital Organization Iwakuni Clinical Center: Ryo Kato; Tsuyama Chuo Hospital: none; Wakayama Medical University: Shinya Taki; Kyoto Second Red Cross Hospital: Koichiro Mandai, Kasumi Sanada, Kojiro Nakase; Japanese Red Cross Society Himeji Hospital: none; Osaka City General Hospital: Hiroko Nebiki; Osaka Red Cross Hospital: none; Okayama Saiseikai General Hospital: Shunsuke Saito; National Hospital Organization Okayama Medical Center: Toshiyuki Wakatsuki; Kitano Hospital: none; Kurashiki Central Hospital: Naoyuki Nishimura; Nara Prefecture Seiwa Medical Center: none. CRediT Authorship Contributions, Yasushi Yamasaki, MD. PhD. (Conceptualization: Lead; Data curation: Equal; Writing ? original draft: Lead), Noriya Uedo, MD. PhD. (Conceptualization: Equal; Data curation: Equal; Methodology: Equal; Writing ? original draft: Lead), Takuji Akamatsu, MD. PhD. (Data curation: Equal; Methodology: Equal), Tomo Kagawa, MD. (Data curation: Equal; Methodology: Equal), Reiji Higashi, MD. PhD. (Data curation: Equal; Methodology: Equal), Osamu Dohi, MD. PhD. (Data curation: Equal; Methodology: Equal), Masanori Furukawa, MD. PhD. (Data curation: Equal; Methodology: Equal), Yu Takahashi, MD. PhD. (Data curation: Equal; Methodology: Equal), Takuya Inoue, MD. PhD. (Data curation: Equal; Methodology: Equal), Shouichi Tanaka, MD. PhD. (Data curation: Equal; Methodology: Equal), Ryuta Takenaka, MD. PhD. (Data curation: Equal; Methodology: Equal), Mikitaka Iguchi, MD. PhD. (Data curation: Equal; Methodology: Equal), Takuji Kawamura, MD. PhD. (Data curation: Equal; Methodology: Equal), Takao Tsuzuki, MD. PhD. (Data curation: Equal; Methodology: Equal), Tomoaki Yamasaki, MD. PhD. (Data curation: Equal; Methodology: Equal), Takeshi Yamashina, MD. PhD. (Data curation: Equal; Methodology: Equal), Junichiro Nasu, MD. PhD. (Data curation: Equal; Methodology: Equal), Tomohiko Mannami, MD. PhD. (Data curation: Equal; Methodology: Equal), Atsushi Yamauchi, MD. PhD. (Data curation: Equal; Methodology: Equal), Kazuhiro Matsueda, MD. PhD. (Data curation: Equal; Methodology: Equal), Shigeyuki Aizawa, MD. PhD. (Data curation: Equal; Methodology: Equal), Toshiharu Mitsuhashi, MD. PhD. (Formal analysis: Lead), Hiroyuki Okada, MD. PhD. (Writing ? review & editing: Equal)
Publisher Copyright:
© 2021 AGA Institute
PY - 2021
Y1 - 2021
N2 - Background and aims: Endoscopic resection of nonampullary duodenal adenoma is often challenging, and its technique has not yet been standardized. To overcome the practical difficulty of conventional endoscopic mucosal resection, underwater endoscopic mucosal resection (UEMR) was recently developed; therefore, we investigated the effectiveness and safety of UEMR for nonampullary duodenal adenoma. Methods: A multicenter, prospective cohort study was conducted at 21 institutions in Japan. We enrolled patients with no more than 2 nonampullary duodenal adenomas ≤20 mm in size, who were planned to undergo UEMR. After UEMR, follow-up endoscopies were scheduled at 2 and 12 months after the procedure, and biopsy specimens were taken from the post-UEMR scars. The primary endpoint was the proportion of patients with histologically proven nonrecurrence at follow-up endoscopy and biopsy. Results: A total of 155 patients with 166 lesions underwent UEMR. One patient with a non-neoplastic lesion in the resected specimen and 10 patients with 10 lesions who were lost to follow-up were excluded. Finally, 144 patients with 155 lesions who received all follow-up endoscopies were analyzed for the primary endpoint. The proportion of patients with proven nonrecurrence was 97.2% (n = 140 of 144; 95% confidence interval, 92.8%–99.1%) which exceeded the predefined threshold value (92%). Two cases of delayed bleeding (1.2%) occurred and they were successfully managed by clips. All recurrences were successfully treated by additional endoscopic treatment. Conclusions: This multicenter, prospective cohort study demonstrated effectiveness and safety of UEMR for nonampullary duodenal adenomas ≤20 mm in size. (University Hospital Medical Network Clinical Trials Registry, Number: UMIN000030414).
AB - Background and aims: Endoscopic resection of nonampullary duodenal adenoma is often challenging, and its technique has not yet been standardized. To overcome the practical difficulty of conventional endoscopic mucosal resection, underwater endoscopic mucosal resection (UEMR) was recently developed; therefore, we investigated the effectiveness and safety of UEMR for nonampullary duodenal adenoma. Methods: A multicenter, prospective cohort study was conducted at 21 institutions in Japan. We enrolled patients with no more than 2 nonampullary duodenal adenomas ≤20 mm in size, who were planned to undergo UEMR. After UEMR, follow-up endoscopies were scheduled at 2 and 12 months after the procedure, and biopsy specimens were taken from the post-UEMR scars. The primary endpoint was the proportion of patients with histologically proven nonrecurrence at follow-up endoscopy and biopsy. Results: A total of 155 patients with 166 lesions underwent UEMR. One patient with a non-neoplastic lesion in the resected specimen and 10 patients with 10 lesions who were lost to follow-up were excluded. Finally, 144 patients with 155 lesions who received all follow-up endoscopies were analyzed for the primary endpoint. The proportion of patients with proven nonrecurrence was 97.2% (n = 140 of 144; 95% confidence interval, 92.8%–99.1%) which exceeded the predefined threshold value (92%). Two cases of delayed bleeding (1.2%) occurred and they were successfully managed by clips. All recurrences were successfully treated by additional endoscopic treatment. Conclusions: This multicenter, prospective cohort study demonstrated effectiveness and safety of UEMR for nonampullary duodenal adenomas ≤20 mm in size. (University Hospital Medical Network Clinical Trials Registry, Number: UMIN000030414).
KW - Duodenal Adenoma
KW - Follow-Up
KW - Nonrecurrence Rate
KW - Underwater Endoscopic Mucosal Resection
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UR - http://www.scopus.com/inward/citedby.url?scp=85120346071&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2021.06.043
DO - 10.1016/j.cgh.2021.06.043
M3 - Article
C2 - 34217879
AN - SCOPUS:85120346071
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
SN - 1542-3565
ER -