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Clinical Trial
. 2024 Feb 19;24(1):231.
doi: 10.1186/s12885-024-11957-9.

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 #  1 , Tadayoshi Hashimoto #  2   3   4 , Junki Mizusawa  2 , Ryo Kitabayashi  2 , Yusuke Sano  2 , Haruhiko Fukuda  2 , Kohei Nakata  1 , Kazuto Shibuya  5 , Yuji Kitahata  6 , Minoru Takada  7 , Keiko Kamei  8 , Hiroshi Kurahara  9 , Daisuke Ban  10 , Shogo Kobayashi  11 , Hiroaki Nagano  12 , Hajime Imamura  13 , Michiaki Unno  14 , Amane Takahashi  15 , Shintaro Yagi  16 , Hiroshi Wada  17 , Hirofumi Shirakawa  18 , Naoto Yamamoto  19 , Seiko Hirono  20 , Naoto Gotohda  21 , Etsuro Hatano  22 , Masafumi Nakamura  23 , Makoto Ueno  24 ; on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology Group
Affiliations
Clinical Trial

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 et al. BMC Cancer. .

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 ].

Keywords: Clinical trial; Laparoscopy; Minimally invasive surgical procedures; Pancreatectomy; Pancreatic neoplasm.

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Conflict of interest statement

Dr. Mizusawa reports grants from Ministry of Health, Labour and Welfare, Japan, during the conduct of the study; lecture fees from Taiho Pharmaceutical and Chugai Pharmaceutical outside the submitted work; his spouse is an employee of Pfizer; Dr. Fukuda reports lecture fees from Kyowa Kirin Co., Ltd., Chugai Pharmaceutical, and CMIC Co., Ltd. outside the submitted work; Dr. Unno reports grants from Taiho Pharmaceutical, Takeda Pharmaceutical, Chugai Pharmaceutical, and Asahi-Kasei Pharmaceutical during the conduct of the study; Dr. Nakamura reports grants from Taiho Pharmaceutical, Chugai Pharmaceutical, Covidien Japan Inc. during the conduct of the study.

Figures

Fig. 1
Fig. 1
Schematics of this study
See this image and copyright information in PMC

References

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