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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01696903

Enrollment

123

Registered

2012-10-02

Start date

2011-09-30

Completion date

2015-11-30

Last updated

2017-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Fistula

Keywords

Postoperative pancreatic fistula, Pancreatic texture, Pancreatic duct diameter, Pancreatic consistency, Pancreaticoduodenectomy

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.

Interventions

PROCEDUREPancreaticojejunostomy 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Severity of postoperative complications	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026