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POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection (PORSCH)

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ClinicalTrials.gov Identifier: NCT03400280
Recruitment Status : Unknown
Verified June 2019 by HC van Santvoort, St. Antonius Hospital.
Recruitment status was:  Recruiting
First Posted : January 17, 2018
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
HC van Santvoort, St. Antonius Hospital

Study Description
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Brief Summary:
This Nationwide stepped-wedge cluster randomized trial is designed to evaluate if the implementation of a best practice algorithm for postoperative care results in a decrease in incidence of major complications and death after pancreatic resection as compared to current practice.

Condition or disease Intervention/treatment Phase
Pancreatic Diseases Pancreatic Neoplasms Pancreatic Cancer Pancreatitis Other: Best practice algorithm for postoperative care Not Applicable

Detailed Description:

Rationale

Pancreatic resection is a major abdominal operation with 50% chance of postoperative complications. A feared complication is severe pancreatic fistula, in which there is leakage of enzyme rich fluid into the abdominal cavity. Adequate complication management appears to be the most important factor in improving outcomes of patients undergoing pancreatic resection.

Objective

To investigate whether implementation of a best practice algorithm for postoperative care focusing on early detection and step-up management of postoperative pancreatic fistula results in a lower rate of major complications and death after pancreatic resection as compared to current practice

Study design

A nationwide stepped-wedge, cluster randomized, superiority trial. In this design all participating centers cross over from current practice to best practice according to the algorithm, but are randomized to determine the exact order. At the end of the trial, all centers will have implemented the best practice algorithm.

Study population

All centers performing pancreatic surgery in the Netherlands (i.e. the Dutch Pancreatic Cancer Group).

Intervention

Cluster level education on postoperative care according to a best practice algorithm, focusing on early detection and step-up management of postoperative pancreatic fistula. This algorithm is based on findings in Dutch observational cohort studies, systematic literature analyses, an inventory in current protocols on postoperative care and expert opinion. The proposed algorithm is validated in a multicenter cohort and consensus upon this algorithm is reached with pancreatic surgeons from all centers of the Dutch Pancreatic Cancer Group. The final algorithm was reviewed critically by the advisory committee of internationally respected experts in the field of pancreatology before implementation in this trial.

Comparison

Postoperative care according to current practice.

Endpoints

The primary outcome was measured in all patients undergoing pancreatic resection and is a composite of major complications (i.e. postpancreatectomy bleeding, new-onset organ failure and death). Secondary endpoints include the individual components of the primary endpoint and other clinical outcomes, number of patients receiving adjuvant chemotherapy, healthcare resource utilization and costs analysis. Follow-up will be 90 days after pancreatic resection.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Stepped-wedge cluster randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection. a Nationwide Stepped-Wedge Cluster Randomized Trial
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : November 9, 2019
Estimated Study Completion Date : February 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arms and Interventions
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Arm Intervention/treatment
Experimental: Best practice
Postoperative care according to a best practice algorithm for postoperative care focussing on early detection and minimally invasive management of postoperative pancreatic fistula.
 Other: Best practice algorithm for postoperative care
See arm/group description
No Intervention: Current practice
Postoperative care according to current usual practice.


Outcome Measures
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Primary Outcome Measures :
  1. Composite primary endpoint [ Time Frame: 90 days after index pancreatic resection ]
    The primary endpoint of this trial is a composite of the most severe complications associated to postoperative pancreatic fistula. This endpoint will be considered positive if one of the following complications occurs within 90 days after pancreatic resection: late postpancreatectomy bleeding, new-onset organ failure and/or death


Secondary Outcome Measures :
  1. Postoperative mortality [ Time Frame: 90 days after index pancreatic resection ]
    Measured as rate of death at 90-day follow-up

  2. New-onset organ failure [ Time Frame: 90 days after index pancreatic resection ]
    Measured as organ failure occuring any time within 90 days after resection, not present at time of index pancreatic resection.

  3. Late postpancreatectomy bleeding [ Time Frame: 90 days after index pancreatic resection ]
    Defined in accordance to the International Study Group on Pancreatic Surgery (ISGPS) definition as bleeding occurring any time after 24 hours after pancreatic resection.

  4. Postoperative morbidity [ Time Frame: 90 days after index pancreatic resection ]
    Including complications according to the Clavien-Dindo system and pancreatectomy specific complications according to the ISGPS definitions (e.g. postpancreatectomy bleeding, postoperative pancreatic fistula, postoperative bile leak, postoperative chyle leak and delayed gastric emptying).

  5. Adjuvant chemotherapy [ Time Frame: 90 days after index pancreatic resection ]
    Measured as number of patients receiving adjuvant chemotherapy at 90-day follow-up

  6. Success of implementation [ Time Frame: 90 days after index pancreatic resection ]
    Measured as number of patients in whom the algorithm was not followed and timing of abdominal CT scans in both strategies.

  7. Cost-effectiveness [ Time Frame: 90 days after index pancreatic resection ]
    Calculated by comparing health effects and medical costs related to both strategies up to 90 days after pancreatic resection.


Eligibility Criteria
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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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Clusters:

  • All Dutch centers performing pancreatic surgery (i.e. performing at least 20 pancreatoduodenectomies a year)

Exclusion Criteria for Clusters:

  • None

Inclusion Criteria for Patients:

  • Patients underoging pancreatic resection for any indication

Exclusion Criteria for Patients:

  • None (i.e. complete enumeration)
Contacts and Locations
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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): NCT03400280


Contacts
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Contact: Jasmijn Smits, MD +31887571207 porsch@dpcg.nl
Contact: Hjalmar C van Santvoort, MD, PhD +31887556489 h.vansantvoort@umcutrecht.nl

Locations
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Sponsors and Collaborators
St. Antonius Hospital
Dutch Cancer Society
Investigators
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Principal Investigator: Quintus Molenaar, MD, PhD UMC Utrecht
Principal Investigator: Hjalmar C van Santvoort, MD, PhD St. Antonius ziekenhuis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: HC van Santvoort, Principal Investigator, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT03400280    
Other Study ID Numbers: W17.057
UU2017-8272 ( Other Grant/Funding Number: Dutch Cancer Society (KWF) )
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The datasets generated during and/or analysed during the current study are/will be available upon request from Hjalmar van Santvoort (h.van.santvoort@antoniusziekenhuis.nl)
Supporting Materials: Study Protocol
Time Frame: Upon request
Access Criteria: Upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HC van Santvoort, St. Antonius Hospital:
Postoperative pancreatic fistula
Pancreatic resection
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatitis
Pancreatic Diseases
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases