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

September 12, 2019 updated by: Azienda Ospedaliera Universitaria Integrata Verona

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy, 37134
        • Ospedale Policlinico GB Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
30 days post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
POPF severity
Time Frame: 30 days post-operative
POPF grade B and grade C rates
30 days post-operative
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
1 year
Mortality
Time Frame: 90 days
Death related to surgical morbidity
90 days
Post-Pancreatectomy Hemorrhage
Time Frame: 90 days
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
90 days
Delayed Gastric Emptying
Time Frame: 90 days
As defined by ISGPS, grade A, B and C rates
90 days
Biliary fistula
Time Frame: 90 days
Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out
90 days
Gastrojejunal/Duodenojejunal fistula
Time Frame: 90 days
Fistula from gastro/duodenojejunostomy
90 days
Abdominal abscess
Time Frame: 90 days
Collection >5cm in size, containing gas bubbles, determining systemic signs of infection
90 days
Acute pancreatitis
Time Frame: 1 day post index surgery
Altered serum amylase count on POD 0 or POD 1
1 day post index surgery
Wound infection
Time Frame: 90 days
Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention
90 days
Blood transfusions
Time Frame: 90 days
Need and number of packed red blood cells transfused
90 days
Myocardial infarction
Time Frame: 90 days
Myocardial necrosis
90 days
Acute Kidney Failure
Time Frame: 90 days
Abrupt change in serum creatinine >1.5 baseline value
90 days
Pulmonary Embolism
Time Frame: 90 days
Blood clots in the pulmonary arterial system
90 days
Pneumonia
Time Frame: 90 days
Bacterial infection of the lungs
90 days
Respiratory insufficiency
Time Frame: 90 days
Need for re-intubation
90 days
Urinary Tract Infection
Time Frame: 90 days
Bacterial infection of the urinary tract
90 days
Cerebrovascular accidents
Time Frame: 90 days
Stroke, hemorrhage, brain death
90 days
Reoperation
Time Frame: 90 days
Need for new surgery due to severe morbidity
90 days
Readmission
Time Frame: 30 days after hospital discharge
New admission within 30-days of discharge from hospital
30 days after hospital discharge
Time-to-adjuvant therapy
Time Frame: 1 year
Time form index operation to the beginning of adjuvant treatment (only for malignancy)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Ospedaliera Universitaria Integrata Verona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claudio Bassi, MD, Università degli studi di Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PREP 1041CESC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual Participant Data will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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