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

Not Applicable

Completed

• Conditions: Pancreatic Fistula
• Interventions: Procedure: Pancreaticogastrostomy with external drain; Procedure: Pancreaticojejunostomy with transanastomotic drain

• Registration Number: NCT03212196
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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.

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 Timeline

• Study First Submitted: 2016-11-09
• Study Start: 2017-06-12
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-11
• Primary Completion: 2019-06-10
• Study Completion: 2019-07-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-12
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pancreaticogastrostomy	Pancreaticogastrostomy with external drain	Pancreaticogastrostomy with external drain
Pancreaticojejunostomy	Pancreaticojejunostomy with transanastomotic drain	Pancreaticojejunostomy with transanastomotic drain

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Urinary Tract Infection	90 days	Bacterial infection of the urinary tract
Respiratory insufficiency	90 days	Need for re-intubation
Cerebrovascular accidents	90 days	Stroke, hemorrhage, brain death
Delayed Gastric Emptying	90 days	As defined by ISGPS, grade A, B and C rates
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
Pneumonia	90 days	Bacterial infection of the lungs
Post-Pancreatectomy Hemorrhage	90 days	As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Myocardial infarction	90 days	Myocardial necrosis
Acute Kidney Failure	90 days	Abrupt change in serum creatinine \>1.5 baseline value
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
Biliary fistula	90 days	Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out
POPF severity	30 days post-operative	POPF grade B and grade C rates
Mortality	90 days	Death related to surgical morbidity
Gastrojejunal/Duodenojejunal fistula	90 days	Fistula from gastro/duodenojejunostomy
Acute pancreatitis	1 day post index surgery	Altered serum amylase count on POD 0 or POD 1
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
Abdominal abscess	90 days	Collection \>5cm in size, containing gas bubbles, determining systemic signs of infection
Pulmonary Embolism	90 days	Blood clots in the pulmonary arterial system
Time-to-adjuvant therapy	1 year	Time form index operation to the beginning of adjuvant treatment (only for malignancy)

Trial Locations

Locations (1)

Ospedale Policlinico GB Rossi; 🇮🇹 Verona, Italy