Evidence map›Paper›PMID 38331727›Full record

ArticleBMC gastroenterology2024

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).

Kazunori Takada, Kenichiro Imai, Takanori Yamada, Ken Ohata, Takashi Kanesaka, Yasuaki Nagami, Yasushi Yamasaki, Hideki Kobara, Yasuhiro Inokuchi, Akiko Chino and 26 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.9field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. An Update on the Management of Rectal Neuroendocrine Neoplasms.Current treatment options in oncology · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

36 authors at 20 institutions in 1 country.

Kazunori TakadaDivision of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, NagaizumiShizuoka, 411-8777, Japan.
Kenichiro ImaiDivision of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, NagaizumiShizuoka, 411-8777, Japan. k.imai1977@gmail.com.
Takanori YamadaDepartment of Gastroenterology, Iwata City Hospital, Shizuoka, Japan.
Ken OhataDepartment of Gastroenterology, NTT Medical Center Tokyo, Tokyo, Japan.
Takashi KanesakaDepartment of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.
Yasuaki NagamiDepartment of Gastroenterology, Osaka Metropolitan University Graduate School of Medicine, Osaka, Japan.
Yasushi YamasakiDepartment of Gastroenterology, Okayama University Hospital, Okayama, Japan.
Hideki KobaraDepartment of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Takamatsu, Japan.
Yasuhiro InokuchiDepartment of Gastroenterology, Kanagawa Cancer Center, Kanagawa, Japan.
Akiko ChinoDepartment of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Shinjiro YamaguchiDivision of Gastroenterology, Kansai Rosai Hospital, Hyogo, Japan.
Hisatomo IkeharaDepartment of Gastroenterology, Kitasato University School of Medicine, Kanagawa, Japan.
Takuji KawamuraDepartment of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan.
Yohei YabuuchiDepartment of Gastroenterology, Kobe City Medical Center General Hospital, Hyogo, Japan.
Yasuhiko MizuguchiEndoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
Hiroaki IkematsuDepartment of Gastroenterology and Endoscopy, National Cancer Center Hospital East, Chiba, Japan.
Chizu YokoiEndoscopy Division, National Center for Global Health and Medicine, Tokyo, Japan.
Santa HattoriGastrointestinal Center, Sano Hospital, Hyogo, Japan.
Kazuya OhnoDepartment of Gastroenterology, Shizuoka General Hospital, Shizuoka, Japan.
Yashiro YoshizawaDepartment of Gastroenterology, Seirei Hamamatsu General Hospital, Shizuoka, Japan.
Masakatsu FukuzawaDepartment of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan.
Yosuke TsujiNext-Generation Endoscopic Computer Vision, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan.
Jun KonishiDepartment of Gastroenterology, Tochigi Cancer Center, Tochigi, Japan.
Takeshi YamamuraDepartment of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Aichi, Japan.
Satoshi OsawaDepartment of Endoscopic and Photodynamic Medicine, Hamamatsu University School of Medicine, Shizuoka, Japan.
Shiro OkaDepartment of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan.
Takuto HikichiDepartment of Endoscopy, Fukushima Medical University Hospital, Fukushima, Japan.
Kazutomo TogashiDepartment of Coloproctology, Aizu Medical Center, Fukushima Medical University, Fukushima, Japan.
Kingo HirasawaDivision of Endoscopy, Yokohama City University Medical Center, Yokohama, Japan.
Toshio UraokaDepartment of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine, Gunma, Japan.
Yoji TakeuchiDepartment of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.
Hideyuki ChibaDepartment of Gastroenterology, Omori Red Cross Hospital, Tokyo, Japan.
Yoriaki KomedaDepartment of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan.
Hisashi DoyamaDepartment of Gastroenterology, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.
Mari S ObaDepartment of Clinical Data Science, Clinical Research and Education Promotion Division, National Center of Neurology and Psychiatry, Tokyo, Japan.
Yutaka SaitoEndoscopy Division, National Cancer Center Hospital, Tokyo, Japan.
National Cancer Center Hospital East · JPOsaka International Cancer Institute · JPShizuoka Cancer Center · JPFukushima Medical University · JPFukushima Medical University Hospital · JPGunma University · JPHamamatsu University School of Medicine · JPHiroshima University Hospital · JPIshikawa Prefectural Central Hospital · JPIwata City Hospital · JPJapanese Foundation For Cancer Research · JPKagawa University · JPKanagawa Cancer CenterKansai Rosai Hospital · JPKindai University · JPKitasato University · JPKobe City Medical Center General Hospital · JPKyoto first Red Cross hospital · JPNagoya University · JPNational Center for Global Health and Medicine · JP

Funding

Japanese Foundation for Research and Promotion of Endoscopy No.21-042
6 · The paper itself

Abstract

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. DISCUSSION: This 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.

Indexed as

Endoscopic Mucosal ResectionNeuroendocrine TumorsRectal NeoplasmsEquivalence Trials as TopicHumansLigationMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicRetrospective StudiesTreatment OutcomeEndoscopic submucosal dissectionLigationNeuroendocrine tumorsRandomized controlled trialResection margin

Identifiers

PMID38331727
PMCPMC10854141
OpenAlexW4391655041

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.