Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Pancreatic Fistula
• Interventions: Procedure: Pancreaticojejunostomy technique

• Registration Number: NCT01696903
• Lead Sponsor: Karolinska Institutet

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 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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-10-02
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Patients scheduled for elective pancreaticoduodenectomy
• Pancreatic gland with high risk criteria for associated postoperative morbidity

Exclusion Criteria

• Patients do not accept participation
• Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novel anastomosis	Pancreaticojejunostomy technique	Novel anastomosis: This the active comparator to the conventional anastomosis. A new pancreaticojejunostomy technique is used for the reconstruction. The pancreas is intubated into the jejunum.

Primary Outcome Measures

Name	Time	Method
Clinically Relevant Postoperative Pancreatic Fistula	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

Secondary Outcome Measures

Name	Time	Method
Associated postoperative morbidity	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.

Trial Locations

Locations (2)

Department of Surgical gastroenterology, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Department of Upper Abdominal Surgery, Linköping University Hospital; 🇸🇪 Linköping, Sweden