Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Karolinska Institute

Status: Completed

Conditions: Pancreatic Fistula

Treatments: Procedure: Pancreaticojejunostomy technique

Study type: Interventional

Funder types: Other

Identifiers

NCT01696903

SKARV-GLH-001

KI-DSGE-DUAS (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Conventional anastomosis

No Intervention group

Description:

Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattell's duct-to-mucosa technique".

Novel anastomosis

Active Comparator group

Description:

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.

Treatment:

Procedure: Pancreaticojejunostomy technique