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

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona (Other)

Overall Status

Completed

CT.gov ID

NCT03212196

Collaborator

(none)

Enrollment

Location

Arms

24.9

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Fistula	Procedure: Pancreaticogastrostomy with external drain Procedure: Pancreaticojejunostomy with transanastomotic drain	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

Technical Strategies for Pancreatic Fistula Prevention After Pancreaticoduodenectomy in High-risk Pancreatic Remnant: a Risk-adjusted Randomized Controlled Trial

Actual Study Start Date :

Jun 12, 2017

Actual Primary Completion Date :

Jun 10, 2019

Actual Study Completion Date :

Jul 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pancreaticogastrostomy Pancreaticogastrostomy with external drain	Procedure: Pancreaticogastrostomy with external drain 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.
Active Comparator: Pancreaticojejunostomy Pancreaticojejunostomy with transanastomotic drain	Procedure: Pancreaticojejunostomy with transanastomotic drain Pancreatico-enteric anastomosis is provided through a double-layer, duct-to-mucosa anastomosis with a transanastomotic externalized drain.

Arm

Intervention/Treatment

Active Comparator: Pancreaticogastrostomy

Pancreaticogastrostomy with external drain

Procedure: Pancreaticogastrostomy with external drain

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.

Active Comparator: Pancreaticojejunostomy

Pancreaticojejunostomy with transanastomotic drain

Procedure: Pancreaticojejunostomy with transanastomotic drain

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

Outcome Measures

Primary Outcome Measures

Post-operative Pancreatic Fistula (POPF) [30 days post-operative]
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

Secondary Outcome Measures

POPF severity [30 days post-operative]
POPF grade B and grade C rates
Length of Hospital Stay [1 year]
calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission
Mortality [90 days]
Death related to surgical morbidity
Post-Pancreatectomy Hemorrhage [90 days]
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Delayed Gastric Emptying [90 days]
As defined by ISGPS, grade A, B and C rates
Biliary fistula [90 days]
Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out
Gastrojejunal/Duodenojejunal fistula [90 days]
Fistula from gastro/duodenojejunostomy
Abdominal abscess [90 days]
Collection >5cm in size, containing gas bubbles, determining systemic signs of infection
Acute pancreatitis [1 day post index surgery]
Altered serum amylase count on POD 0 or POD 1
Wound infection [90 days]
Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention
Blood transfusions [90 days]
Need and number of packed red blood cells transfused
Myocardial infarction [90 days]
Myocardial necrosis
Acute Kidney Failure [90 days]
Abrupt change in serum creatinine >1.5 baseline value
Pulmonary Embolism [90 days]
Blood clots in the pulmonary arterial system
Pneumonia [90 days]
Bacterial infection of the lungs
Respiratory insufficiency [90 days]
Need for re-intubation
Urinary Tract Infection [90 days]
Bacterial infection of the urinary tract
Cerebrovascular accidents [90 days]
Stroke, hemorrhage, brain death
Reoperation [90 days]
Need for new surgery due to severe morbidity
Readmission [30 days after hospital discharge]
New admission within 30-days of discharge from hospital
Time-to-adjuvant therapy [1 year]
Time form index operation to the beginning of adjuvant treatment (only for malignancy)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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