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Completed

NCT Number: NCT03212196

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Policlinico GB Rossi

Verona, 37134, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pancreaticogastrostomy with external drain

Procedure

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 drain

Procedure

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

Primary outcomes

  1. Post-operative Pancreatic Fistula (POPF)

    Time frame: 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 outcomes

  1. POPF severity

    Time frame: 30 days post-operative

    POPF grade B and grade C rates

  2. Length of Hospital Stay

    Time frame: 1 year

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

  3. Mortality

    Time frame: 90 days

    Death related to surgical morbidity

  4. Post-Pancreatectomy Hemorrhage

    Time frame: 90 days

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

  5. Delayed Gastric Emptying

    Time frame: 90 days

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

  6. Biliary fistula

    Time frame: 90 days

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

  7. Gastrojejunal/Duodenojejunal fistula

    Time frame: 90 days

    Fistula from gastro/duodenojejunostomy

  8. Abdominal abscess

    Time frame: 90 days

    Collection >5cm in size, containing gas bubbles, determining systemic signs of infection

  9. Acute pancreatitis

    Time frame: 1 day post index surgery

    Altered serum amylase count on POD 0 or POD 1

  10. Wound infection

    Time frame: 90 days

    Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention

  11. Blood transfusions

    Time frame: 90 days

    Need and number of packed red blood cells transfused

  12. Myocardial infarction

    Time frame: 90 days

    Myocardial necrosis

  13. Acute Kidney Failure

    Time frame: 90 days

    Abrupt change in serum creatinine >1.5 baseline value

  14. Pulmonary Embolism

    Time frame: 90 days

    Blood clots in the pulmonary arterial system

  15. Pneumonia

    Time frame: 90 days

    Bacterial infection of the lungs

  16. Respiratory insufficiency

    Time frame: 90 days

    Need for re-intubation

  17. Urinary Tract Infection

    Time frame: 90 days

    Bacterial infection of the urinary tract

  18. Cerebrovascular accidents

    Time frame: 90 days

    Stroke, hemorrhage, brain death

  19. Reoperation

    Time frame: 90 days

    Need for new surgery due to severe morbidity

  20. Readmission

    Time frame: 30 days after hospital discharge

    New admission within 30-days of discharge from hospital

  21. Time-to-adjuvant therapy

    Time frame: 1 year

    Time form index operation to the beginning of adjuvant treatment (only for malignancy)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

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

Acronym: PREP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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