Clinical Trial: Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula

Brief Summary: Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.

Detailed Summary: 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.
Sponsor: Karolinska Institutet

Current Primary Outcome: Clinically Relevant Postoperative Pancreatic Fistula [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]

Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula


Original Primary Outcome: Same as current

Current Secondary Outcome: Associated postoperative morbidity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]

Postoperative pancreatic fistula and abscesses or fluid collections adjacent to the pancreaticojejunostomy constitute a morbidity event; pancreaticojejunostomy-associated morbidity.


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: September 25, 2012
Date Started: September 2011
Date Completion: September 2015
Last Updated: March 30, 2015
Last Verified: October 2013