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)

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

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.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Humans
  • Japan / epidemiology
  • Laparoscopy* / adverse effects
  • Laparoscopy* / methods
  • Neoplasm Recurrence, Local / surgery
  • Pancreatectomy / adverse effects
  • Pancreatectomy / methods
  • Pancreatic Neoplasms*
  • Postoperative Complications / epidemiology
  • Postoperative Complications / etiology
  • Retrospective Studies
  • Robotic Surgical Procedures* / adverse effects
  • Robotic Surgical Procedures* / methods
  • Treatment Outcome