Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Procedure: Pancreaticojejunostomy technique


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional anastomosis<br>Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to Cattell's duct-to-mucosa technique. | |
| Active Comparator: Novel anastomosis<br>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. | Procedure: Pancreaticojejunostomy technique<br>* 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.<br>* Other names: pancreatojejunostomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Relevant Postoperative Pancreatic Fistula | Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associated postoperative morbidity | Postoperative pancreatic fistula and abscesses or fluid collections adjacent to the pancreaticojejunostomy constitute a morbidity event; pancreaticojejunostomy-associated morbidity. | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pancreatic fistula, Pancreatic texture, Pancreatic duct diameter, Pancreatic consistency, Pancreaticoduodenectomy