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ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a

Ken-Ichi Okada1, Manabu Kawai1, Seiko Hirono1

  • 1Second Department of Surgery, School of Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8510, Japan.

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|September 17, 2021
PubMed
Summary

This study compares a novel isolation technique (RAMPS) against the conventional approach for pancreatic cancer surgery. The isolation procedure aims to improve survival rates for patients undergoing distal pancreatosplenectomy (DPS).

Keywords:
Distal pancreatectomyDistal pancreatosplenectomyIsolationRadical antegrade modular pancreatosplenectomy

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Area of Science:

  • Surgical Oncology
  • Gastrointestinal Surgery
  • Clinical Trials

Background:

  • Radical antegrade modular pancreatosplenectomy (RAMPS) is an isolation technique for pancreatic body/tail cancer surgery.
  • RAMPS aims to isolate blood and lymphatic flow before excising the pancreatic body/tail and spleen.
  • Previous studies suggest RAMPS may reduce blood loss and improve R0 resection rates in pancreatic ductal adenocarcinoma (PDAC).

Purpose of the Study:

  • To investigate if the RAMPS procedure improves survival in PDAC patients undergoing distal pancreatosplenectomy (DPS) compared to the conventional approach.
  • To evaluate the oncological and surgical benefits of the RAMPS isolation procedure.

Main Methods:

  • A randomized controlled trial involving 100 PDAC patients undergoing DPS at Japanese high-volume centers.
  • Patients are randomized to either the conventional procedure (Arm A) or the RAMPS isolation procedure (Arm B).
  • Primary endpoint is 2-year recurrence-free survival; secondary endpoints include intraoperative blood loss, R0 resection rate, and overall survival.

Main Results:

  • Data on main results are not yet available as this is a trial investigation.
  • The study will compare recurrence-free survival, blood loss, and resection rates between the two surgical groups.

Conclusions:

  • If the RAMPS procedure demonstrates improved survival and similar R0 rates, it may become a standard for DPS in PDAC.
  • If no significant differences are found, it will support the justification of either surgical approach.