Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant

Azienda Ospedaliera Universitaria Integrata Verona72 enrolled

Overview

This trial will investigate what surgical technique between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains is associated with the lowest rate of pancreatic fistula after pancreaticoduodenectomy in case of high-risk pancreatic remnants.

Pancreatic fistula is the major determinant of outcome after pancreaticoduodenectomy. Several strategies to reduce the burden of this complication have been proposed in the last decade. A definite answer about what is the best technique to approach a high-risk pancreatic stump is still needed. Both pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains have been proposed in this setting, but often studies do not provide a reliable risk stratification and result are extremely variable. The aim of this trial is to evaluate what surgical technique, between pancreaticogastrostomy and pancreaticojejunostomy with transanastomotic externalized drains, is associated with the lowest rate of pancreatic fistula in case of high-risk pancreatic remnants. Risk stratification will be provided through the Fistula Risk Score, a clinical risk score that has been extensively validated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Pancreatic Fistula

Interventions

Pancreaticogastrostomy with external drainPROCEDURE

Pancreatico-enteric anastomosis is provided according to the "Bassi technique", pancreatic remnant is pushed into the gastric cavity through a posterior gastrotomy. An externalized drain is placed into the main pancreatic duct.

Pancreaticojejunostomy with transanastomotic drainPROCEDURE

Pancreatico-enteric anastomosis is provided through a double-layer, duct-to-mucosa anastomosis with a transanastomotic externalized drain.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All the patients undergoing pancreaticoduodenectomy (only Whipple or Traverso) for all kind of pancreatic disease (benign, malignant or premalignant). * Patients able to give their informed consent Exclusion criteria * Informed consent withdrawal * Impossibility to undergo surgery for any reason * Use of glues or biological matrices to protect the anastomosis * Fistula Risk Score \< 7 * Post-operative octreotide analogues administration (only prophylactic use, therapeutic use allowed) * Wrong randomization

Locations (1)

Ospedale Policlinico GB Rossi

Verona, Italy

Outcomes

Primary Outcomes

Post-operative Pancreatic Fistula (POPF)

Presence of Amylase \> 3 times the upper limit of normal in surgical drains at or by post-operative day 3 (POD) determining a clinically relevant change in patient's management

Time frame: 30 days post-operative

Secondary Outcomes

POPF severity

POPF grade B and grade C rates

Time frame: 30 days post-operative

Length of Hospital Stay

calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission

Time frame: 1 year

Mortality

Death related to surgical morbidity

Time frame: 90 days

Post-Pancreatectomy Hemorrhage

As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates

Time frame: 90 days

Delayed Gastric Emptying

As defined by ISGPS, grade A, B and C rates

Time frame: 90 days

Biliary fistula

Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out

Time frame: 90 days

Gastrojejunal/Duodenojejunal fistula

Fistula from gastro/duodenojejunostomy

Time frame: 90 days

Data from ClinicalTrials.gov

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