BMC Cancer (Feb 2024)

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

DOI
https://doi.org/10.1186/s12885-024-11957-9
Journal volume & issue
Vol. 24, no. 1
pp. 1 – 7

Abstract

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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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