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

Integrated University Hospital Trust of Verona

Status: Completed

Conditions: Pancreatic Fistula

Treatments: Procedure: Pancreaticogastrostomy with external drain; Procedure: Pancreaticojejunostomy with transanastomotic drain

Study type: Interventional

Funder types: Other

Identifiers

NCT03212196

PREP 1041CESC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Pancreaticogastrostomy

Active Comparator group

Description:

Pancreaticogastrostomy with external drain

Treatment:

Procedure: Pancreaticogastrostomy with external drain

Pancreaticojejunostomy

Active Comparator group

Description:

Pancreaticojejunostomy with transanastomotic drain

Treatment:

Procedure: Pancreaticojejunostomy with transanastomotic drain