Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy — COSMOS-DP  

Pancreatic Neoplasms Clinical Trial

Official title: Comparison of Resection During Distal Pancreatectomy of the Splenic Vein Either Together With the Pancreatic Parenchyma or After Isolation: A Multicentre, Prospective, Randomized Phase III Trial

Status Recruiting

Clinical Trial Summary

Eligible patients will be centrally randomized to either Arm A (resection of the splenic vein after isolation from the pancreatic parenchyma) or Arm B (co-resection of the vein together with the pancreas).

Clinical Trial Description

In distal pancreatectomy, it is customary to ligate and divide the splenic vein after isolating it from the pancreatic parenchyma. This is considered essential to prevent disruption of the stump of the splenic vein and the consequent intra-abdominal haemorrhage in the event of pancreatic fistula. This procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of this trial is to confirm the non-inferiority of resection of the splenic vein embedded in the pancreatic parenchyma compared with the conventional technique of isolating the splenic vein before resection during distal pancreatectomy using a mechanical stapler. ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms

• NCT number: NCT02871804
• Study type: Interventional
• Source: Wakayama Medical University
• Contact: Hiroki Yamaue, MD, PhD
• Phone: +81-73-441-0613
• Email: yamaue-h@wakayama-med.ac.jp
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2016
• Completion date: February 2020