Pancreatic Cancer Research

Clinical trialPhase 3Unknown

Combined Resection vs. Separated Resection After Mobilization of Splenic Vein During Distal Pancreatectomy

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

Outcome
Outcome unknown
Phase
Phase 3
Status
Unknown
Study type
Interventional
Start
August 2016
Expected end
February 2020
Enrollment
304 participants
Sites
1
Primary outcomes
the incidence of pancreatic fsitula grade B/C
Sponsor
Other
Results posted
No
Last update
18 August 2016

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Brief summary public domain (ClinicalTrials.gov)

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).

Detailed description public domain (ClinicalTrials.gov)

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.