Evidence map›Paper›PMID 38373949›Full record

ArticleBMC cancer2024

A multi-institutional randomized phase III study comparing minimally invasive distal pancreatectomy versus open distal pancreatectomy for pancreatic cancer; Japan Clinical Oncology Group study JCOG2202 (LAPAN study).

Naoki Ikenaga, Tadayoshi Hashimoto, Junki Mizusawa, Ryo Kitabayashi, Yusuke Sano, Haruhiko Fukuda, Kohei Nakata, Kazuto Shibuya, Yuji Kitahata, Minoru Takada and 18 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 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
2.5field-weighted citation impact, top 9% 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, 9 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. 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

28 authors at 20 institutions in 1 country.

Naoki Ikenaga *Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, 812-8582, Fukuoka, Japan.
Tadayoshi Hashimoto *Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Junki MizusawaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Ryo KitabayashiJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Yusuke SanoJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Haruhiko FukudaJapan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Kohei NakataDepartment of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, 812-8582, Fukuoka, Japan.
Kazuto ShibuyaDepartment of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, Toyama, Japan.
Yuji KitahataSecond Department of Surgery, Wakayama Medical University, Wakayama, Japan.
Minoru TakadaDepartment of Surgery, Teine Keijinkai Hospital, Hokkaido, Japan.
Keiko KameiDepartment of Surgery, Kindai University Faculty of Medicine, Osakasayama, Japan.
Hiroshi KuraharaDepartment of Digestive Surgery, Kagoshima University, Kagoshima, Japan.
Daisuke BanDepartment of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, Tokyo, Japan.
Shogo KobayashiDepartment of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Japan.
Hiroaki NaganoDepartment of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan.
Hajime ImamuraDepartment of Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
Michiaki UnnoDepartment of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.
Amane TakahashiDepartment of Gastroenterological Surgery, Saitama Cancer Center, Saitama, Japan.
Shintaro YagiDepartment of Hepato-Biliary-Pancreatic Surgery and Transplantation, Kanazawa University, Ishikawa, Japan.
Hiroshi WadaDepartment of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.
Hirofumi ShirakawaDepartment of HepatoBiliary-Pancreatic Surgery, Tochigi Cancer Center, Tochigi, Japan.
Naoto YamamotoDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center, Kanagawa, Japan.
Seiko HironoDivision of Hepato-Biliary-Pancreatic Surgery, Department of Gastroenterological Surgery, Hyogo Medical University, Hyogo, Japan.
Naoto GotohdaDepartment of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Chiba, Japan.
Etsuro HatanoDepartment of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Masafumi NakamuraDepartment of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, 812-8582, Fukuoka, Japan. nakamura.masafumi.861@m.kyushu-u.ac.jp.
Makoto UenoDepartment of Gastroenterology, Kanagawa Cancer Center, Kanagawa, Japan.
on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology Group
Japan Clinical Cancer Research Organization · JPKyushu University · JPHyogo University · JPKagoshima University · JPKanagawa Cancer CenterKanagawa Prefectural Hospital Organization · JPKanazawa University · JPKindai University · JPKyoto University · JPNagasaki University · JPNational Cancer Center Hospital East · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JPOsaka University · JPSaitama Cancer Center · JPTeine Keijinkai Hospital · JPTochigi Cancer Center · JPTohoku University · JPTokyo National Hospital · JPUniversity of Toyama · JPWakayama Medical University · JP

Funding

National Cancer Center Research and Development Funds 2020-J-3, 2023-J-03
6 · The paper itself

Abstract

backgroundMinimally invasive distal pancreatectomy (MIDP), including laparoscopic and robotic distal pancreatectomy, has gained widespread acceptance over the last decade owing to its favorable short-term outcomes. However, evidence regarding its oncologic safety is insufficient. In March 2023, a randomized phase III study was launched in Japan to confirm the non-inferiority of overall survival in patients with resectable pancreatic cancer undergoing MIDP compared with that of patients undergoing open distal pancreatectomy (ODP).

methodsThis is a multi-institutional, randomized, phase III study. A total of 370 patients will be enrolled from 40 institutions within 4 years. The primary endpoint of this study is overall survival, and the secondary endpoints include relapse-free survival, proportion of patients undergoing radical resection, proportion of patients undergoing complete laparoscopic surgery, incidence of adverse surgical events, and length of postoperative hospital stay. Only a credentialed surgeon is eligible to perform both ODP and MIDP. All ODP and MIDP procedures will undergo centralized review using intraoperative photographs. The non-inferiority of MIDP to ODP in terms of overall survival will be statistically analyzed. Only if non-inferiority is confirmed will the analysis assess the superiority of MIDP over ODP. DISCUSSION: If our study demonstrates the non-inferiority of MIDP in terms of overall survival, it would validate its short-term advantages and establish its long-term clinical efficacy.

trial registrationThis trial is registered with the Japan Registry of Clinical Trials as jRCT 1,031,220,705 [ https://jrct.niph.go.jp/en-latest-detail/jRCT1031220705 ].

Indexed as

LaparoscopyPancreatic NeoplasmsRobotic Surgical ProceduresClinical Trials, Phase III as TopicHumansJapanMulticenter Studies as TopicNeoplasm Recurrence, LocalPancreatectomyPostoperative ComplicationsRandomized Controlled Trials as TopicRetrospective StudiesTreatment OutcomeClinical trialLaparoscopyMinimally invasive surgical proceduresPancreatectomyPancreatic neoplasm

Identifiers

PMID38373949
PMCPMC10875854
OpenAlexW4391945828

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Registered trials

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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.