Efficacy of endoscopic submucosal resection with a ligation device for small rectal neuroendocrine tumor: study protocol of a multicenter open-label randomized control trial (BANDIT trial)

被引：4

作者：

Takada, Kazunori ^{[1
]}

Imai, Kenichiro ^{[1
]}

Yamada, Takanori ^{[2
]}

Ohata, Ken ^{[3
]}

Kanesaka, Takashi ^{[4
]}

Nagami, Yasuaki ^{[5
]}

Yamasaki, Yasushi ^{[6
]}

Kobara, Hideki ^{[7
]}

Inokuchi, Yasuhiro ^{[8
]}

Chino, Akiko ^{[9
]}

Yamaguchi, Shinjiro ^{[10
]}

Ikehara, Hisatomo ^{[11
]}

Kawamura, Takuji ^{[12
]}

Yabuuchi, Yohei ^{[13
]}

Mizuguchi, Yasuhiko ^{[14
]}

Ikematsu, Hiroaki ^{[15
]}

Yokoi, Chizu ^{[16
]}

Hattori, Santa ^{[17
]}

Ohno, Kazuya ^{[18
]}

Yoshizawa, Yashiro ^{[19
]}

Fukuzawa, Masakatsu ^{[20
]}

Tsuji, Yosuke ^{[21
]}

Konishi, Jun ^{[22
]}

Yamamura, Takeshi ^{[23
]}

Osawa, Satoshi ^{[24
]}

Oka, Shiro ^{[25
]}

Hikichi, Takuto ^{[26
]}

Togashi, Kazutomo ^{[27
]}

Hirasawa, Kingo ^{[28
]}

Uraoka, Toshio ^{[29
]}

Takeuchi, Yoji ^{[4
,29
]}

Chiba, Hideyuki ^{[30
]}

Komeda, Yoriaki ^{[31
]}

Doyama, Hisashi ^{[32
]}

Oba, Mari S. ^{[33
]}

Saito, Yutaka ^{[14
]}

机构：

[1] Shizuoka Canc Ctr, Div Endoscopy, 1007 Shimonagakubo, Shizuoka 4118777, Japan

[2] Iwata City Hosp, Dept Gastroenterol, Shizuoka, Japan

[3] NTT Med Ctr Tokyo, Dept Gastroenterol, Tokyo, Japan

[4] Osaka Int Canc Inst, Dept Gastrointestinal Oncol, Osaka, Japan

[5] Osaka Metropolitan Univ, Grad Sch Med, Dept Gastroenterol, Osaka, Japan

[6] Okayama Univ Hosp, Dept Gastroenterol, Okayama, Japan

[7] Kagawa Univ, Fac Med, Dept Gastroenterol & Neurol, Takamatsu, Japan

[8] Kanagawa Canc Ctr, Dept Gastroenterol, Yokohama, Kanagawa, Japan

[9] Japanese Fdn Canc Res, Canc Inst Hosp, Dept Gastroenterol, Tokyo, Japan

[10] Kansai Rosai Hosp, Div Gastroenterol, Amagasaki, Hyogo, Japan

[11] Kitasato Univ, Sch Med, Dept Gastroenterol, Kanagawa, Japan

[12] Kyoto Second Red Cross Hosp, Dept Gastroenterol, Kyoto, Japan

[13] Kobe City Med Ctr Gen Hosp, Dept Gastroenterol, Hyogo, Japan

[14] Natl Canc Ctr, Div Endoscopy, Tokyo, Japan

[15] Natl Canc Ctr Hosp East, Dept Gastroenterol & Endoscopy, Chiba, Japan

[16] Natl Ctr Global Hlth & Med, Endoscopy Div, Tokyo, Japan

[17] Sano Hosp, Gastrointestinal Ctr, Hyogo, Japan

[18] Shizuoka Prefectural Gen Hosp, Dept Gastroenterol, Shizuoka, Japan

[19] Seirei Hamamatsu Gen Hosp, Dept Gastroenterol, Shizuoka, Japan

[20] Tokyo Med Univ, Dept Gastroenterol & Hepatol, Tokyo, Japan

[21] Univ Tokyo, Grad Sch Med, Next Generat Endoscop Comp Vis, Tokyo, Japan

[22] Tochigi Canc Ctr, Dept Gastroenterol, Tochigi, Japan

[23] Nagoya Univ, Grad Sch Med, Dept Gastroenterol & Hepatol, Nagoya, Aichi, Japan

[24] Hamamatsu Univ, Dept Endoscop & Photodynam Med, Sch Med, Hamamatsu, Shizuoka, Japan

[25] Hiroshima Univ Hosp, Dept Endoscopy, Hiroshima, Japan

[26] Fukushima Med Univ Hosp, Dept Endoscopy, Fukushima, Japan

[27] Fukushima Med Univ, Aizu Med Ctr, Dept Coloproctol, Fukushima, Japan

[28] Yokohama City Univ, Med Ctr, Div Endoscopy, Yokohama, Japan

[29] Gunma Univ, Grad Sch Med, Dept Gastroenterol & Hepatol, Gunma, Japan

[30] Omori Red Cross Hosp, Dept Gastroenterol, Tokyo, Japan

[31] Kindai Univ, Fac Med, Dept Gastroenterol & Hepatol, Osaka, Japan

[32] Ishikawa Prefectural Cent Hosp, Dept Gastroenterol, Ishikawa, Japan

[33] Natl Ctr Neurol & Psychiat, Dept Clin Data Sci, Clin Res & Educ Promot Div, Tokyo, Japan

来源：

BMC GASTROENTEROLOGY | 2024年 / 24卷 / 01期

关键词：

Endoscopic submucosal dissection; Ligation; Neuroendocrine tumors; Randomized controlled trial; Resection margin; CARCINOID-TUMORS; MUCOSAL RESECTION; CONSENSUS GUIDELINES; TREATMENT OUTCOMES; DISSECTION; THERAPIES;

D O I：

10.1186/s12876-024-03130-0

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

BackgroundEndoscopic resection is widely accepted as a local treatment for rectal neuroendocrine tumors sized <= 10 mm. However, there is no consensus on the best method for the endoscopic resection of rectal neuroendocrine tumors. As a simplified endoscopic procedure, endoscopic submucosal resection with a ligation device (ESMR-L) indicates a histologically complete resection rate comparable to that of endoscopic submucosal dissection (ESD). We hypothesized that ESMR-L than ESD would be preferred for rectal neuroendocrine tumors. Hence, this trial aimed to verify whether ESMR-L is non-inferior to ESD in terms of histologically complete resection rate.MethodsThis is a prospective, open-label, multicenter, non-inferiority, randomized controlled trial of two parallel groups, conducted at the Shizuoka Cancer Center and 31 other institutions in Japan. Patients with a lesion endoscopically diagnosed as a rectal neuroendocrine tumor <= 10 mm are eligible for inclusion. A total of 266 patients will be recruited and randomized to undergo either ESD or ESMR-L. The primary endpoint is the rate of en bloc resection with histologically tumor-free margins (R0 resection). Secondary endpoints include en bloc resection rate, procedure time, adverse events, hospitalization days, total devices and agents cost, adverse event rate between groups with and without resection site closure, outcomes between expert and non-expert endoscopists, and factors associated with R0 resection failure. The sample size is determined based on the assumption that the R0 resection rate will be 95.2% in the ESD group and 95.3% in the ESMR-L group, with a non-inferiority margin of 8%. With a one-sided significance level of 0.05 and a power of 80%, 226 participants are required. Assuming a dropout rate of 15%, 266 patients will be included in this study.DiscussionThis is the first multicenter randomized controlled trial comparing ESD and ESMR-L for the R0 resection of rectal neuroendocrine tumors <= 10 mm. This will provide valuable information for standardizing endoscopic resection methods for rectal neuroendocrine tumors.Trial registrationJapan Registry of Clinical Trials, jRCTs042210124. Registered on Jan 6, 2022.

引用

页数：10

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