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,
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
Affiliations
Naoki Ikenaga
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Tadayoshi Hashimoto
Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital
Junki Mizusawa
Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital
Ryo Kitabayashi
Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital
Yusuke Sano
Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital
Haruhiko Fukuda
Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Center Hospital
Kohei Nakata
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Kazuto Shibuya
Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama
Yuji Kitahata
Second Department of Surgery, Wakayama Medical University
Minoru Takada
Department of Surgery, Teine Keijinkai Hospital
Keiko Kamei
Department of Surgery, Kindai University Faculty of Medicine
Hiroshi Kurahara
Department of Digestive Surgery, Kagoshima University
Daisuke Ban
Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital
Shogo Kobayashi
Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University
Hiroaki Nagano
Department of Gastroenterological, Breast and Endocrine Surgery, Yamaguchi University Graduate School of Medicine
Hajime Imamura
Department of Surgery, Nagasaki University Graduate School of Biomedical Sciences
Michiaki Unno
Department of Surgery, Tohoku University Graduate School of Medicine
Amane Takahashi
Department of Gastroenterological Surgery, Saitama Cancer Center
Shintaro Yagi
Department of Hepato-Biliary-Pancreatic Surgery and Transplantation, Kanazawa University
Hiroshi Wada
Department of Gastroenterological Surgery, Osaka International Cancer Institute
Hirofumi Shirakawa
Department of HepatoBiliary-Pancreatic Surgery, Tochigi Cancer Center
Naoto Yamamoto
Department of Gastrointestinal Surgery, Kanagawa Cancer Center
Seiko Hirono
Division of Hepato-Biliary-Pancreatic Surgery, Department of Gastroenterological Surgery, Hyogo Medical University
Naoto Gotohda
Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East
Etsuro Hatano
Department of Surgery, Graduate School of Medicine, Kyoto University
Masafumi Nakamura
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Makoto Ueno
Department of Gastroenterology, Kanagawa Cancer Center
on behalf of the Hepatobiliary and Pancreatic Oncology Group in Japan Clinical Oncology Group
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 ].
