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Open Access 01-12-2024 | Pancreatectomy | Study Protocol

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)

Authors: Naoki Ikenaga, Tadayoshi Hashimoto, Junki Mizusawa, Ryo Kitabayashi, Yusuke Sano, Haruhiko Fukuda, Kohei Nakata, Kazuto Shibuya, Yuji Kitahata, Minoru Takada, Keiko Kamei, Hiroshi Kurahara, Daisuke Ban, Shogo Kobayashi, Hiroaki Nagano, Hajime Imamura, Michiaki Unno, Amane Takahashi, Shintaro Yagi, Hiroshi Wada, Hirofumi Shirakawa, Naoto Yamamoto, Seiko Hirono, Naoto Gotohda, Etsuro Hatano, Masafumi Nakamura, Makoto Ueno, on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology Group

Published in: BMC Cancer | Issue 1/2024

Abstract

Background

Minimally 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).

Methods

This 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 registration

This 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].

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Title: 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)
Authors: Naoki Ikenaga
Tadayoshi Hashimoto
Junki Mizusawa
Ryo Kitabayashi
Yusuke Sano
Haruhiko Fukuda
Kohei Nakata
Kazuto Shibuya
Yuji Kitahata
Minoru Takada
Keiko Kamei
Hiroshi Kurahara
Daisuke Ban
Shogo Kobayashi
Hiroaki Nagano
Hajime Imamura
Michiaki Unno
Amane Takahashi
Shintaro Yagi
Hiroshi Wada
Hirofumi Shirakawa
Naoto Yamamoto
Seiko Hirono
Naoto Gotohda
Etsuro Hatano
Masafumi Nakamura
Makoto Ueno
on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology Group
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: Pancreatectomy
Pancreatic Cancer
Pancreatic Cancer
Laparoscopy
Minimally Invasive Surgery
Published in: BMC Cancer / Issue 1/2024
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-024-11957-9

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