Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula
Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in
the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the
main contributor of severe postoperative morbidity after pancreaticoduodenectomy.
Characteristics of the pancreatic gland like soft pancreatic consistency and small
pancreatic main duct predispose for the postoperative fistula development. In high risk
patients, the risk of suffering from associated postoperative morbidity is 50 percent which
is considered unacceptable high. The aim of the current trial is to investigate whether a
new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of
associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinically Relevant Postoperative Pancreatic Fistula
Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Ralf Segersvärd, MD, PhD
Sweden: National Board of Health and Welfare