Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial

Trials
Suguru YamadaHiroki Yamaue

Abstract

In distal pancreatectomy (DP), 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 consequent intra-abdominal haemorrhage in the event of pancreatic fistula (PF). However, this procedure can be technically demanding, especially when the vein is firmly embedded in the pancreatic parenchyma. The objective of the COSMOS-DP 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 DP using a mechanical stapler. Patients with diseases of the pancreatic body and tail whose pancreatic parenchyma and splenic vein can be divided concurrently during open or laparoscopic DP are considered eligible for inclusion. This study is designed as a multicentre prospective randomised phase III trial. Eligible patients will be centrally randomised 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). This study aims to establish the non-inferiority of the safety ...Continue Reading

References

Jan 22, 2004·Surgical Endoscopy·S ShimizuK Yamaguchi
Aug 25, 2004·Journal of the American College of Surgeons·Ichiro UyamaAkitake Hasumi
Jul 9, 2005·Surgery·Claudio BassiUNKNOWN International Study Group on Pancreatic Fistula Definition
Jul 17, 2012·Journal of Gastrointestinal Surgery : Official Journal of the Society for Surgery of the Alimentary Tract·Timothy I CarterErnest L Rosato
May 23, 2014·The New England Journal of Medicine·Peter J AllenWilliam R Jarnagin

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Methods Mentioned

BETA
dissection
pancreatectomy

Software Mentioned

SPIRIT
COSMOS
DP

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