학술논문
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)
Document Type
Original Paper
Author
Ikenaga, Naoki; Hashimoto, Tadayoshi; Mizusawa, Junki; Kitabayashi, Ryo; Sano, Yusuke; Fukuda, Haruhiko; Nakata, Kohei; Shibuya, Kazuto; Kitahata, Yuji; Takada, Minoru; Kamei, Keiko; Kurahara, Hiroshi; Ban, Daisuke; Kobayashi, Shogo; Nagano, Hiroaki; Imamura, Hajime; Unno, Michiaki; Takahashi, Amane; Yagi, Shintaro; Wada, Hiroshi; Shirakawa, Hirofumi; Yamamoto, Naoto; Hirono, Seiko; Gotohda, Naoto; Hatano, Etsuro; Nakamura, Masafumi; Ueno, Makoto
Source
BMC Cancer. 24(1)
Subject
Language
English
ISSN
1471-2407
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].