Pancreatic Fistula Clinical Trial
Official title:
Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant: a Risk-adjusted Randomized Controlled Trial
This trial will investigate what surgical technique between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains is associated with the lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk pancreatic remnants.
Pancreatic fistula is the major determinant of outcome after pancreaticoduodenectomy. Several
strategies to reduce the burden of this complication have been proposed in the last decade. A
definite answer about what is the best technique to approach a high-risk pancreatic stump is
still needed. Both pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic
externalized drains have been proposed in this setting, but often studies do not provide a
reliable risk stratification and result are extremely variable.
The aim of this trial is to evaluate what surgical technique, between pancreaticogastrostomy
and pancreaticojejunostomy with transanastomotic externalized drains, is associated with the
lowest rate of pancreatic fistula in case of high-risk pancreatic remnants. Risk
stratification will be provided through the Fistula Risk Score, a clinical risk score that
has been extensively validated.
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