Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 123
- Locations
- 2
- Primary Endpoint
- Clinically Relevant Postoperative Pancreatic Fistula
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional anastomosis
Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattell's duct-to-mucosa technique".
Novel anastomosis
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.
Intervention: Pancreaticojejunostomy technique (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Associated postoperative morbidity(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
Investigators
Christoph Ansorge
Christoph Ansorge, MD, PhD
Karolinska Institutet