NCT01696903

Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Pancreatic Fistula

Interventions

Type	Name	Description
PROCEDURE	Pancreaticojejunostomy technique	The anastomosis between jejunum and remnant pancreas has a pivotal impact on the incidence of postoperative pancreatic fistula. by this novel technique the remnant pancreas is intubated into the jejunum without extensive manipulation.

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2012-10-02
• Last updated: 2017-12-20

Locations

2 sites across 1 country: Sweden