Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03212196
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pancreatic Fistula Procedure: Pancreaticogastrostomy with external drain Procedure: Pancreaticojejunostomy with transanastomotic drain Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : June 12, 2017
Actual Primary Completion Date : June 10, 2019
Actual Study Completion Date : July 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212196


Locations
Layout table for location information
Italy
Ospedale Policlinico GB Rossi
Verona, Italy, 37134
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Investigators
Layout table for investigator information
Principal Investigator: Claudio Bassi, MD Università degli Studi di Verona
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT03212196    
Other Study ID Numbers: PREP 1041CESC
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be shared with other researchers

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Ospedaliera Universitaria Integrata Verona:
Pancreaticoduodenectomy
Pancreaticogastrostomy
Pancreaticojejunostomy
Stent
Transanastomotic drain
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Fistula
Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases