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

POstopeRative Standardization of Care: THe Implementation of Best Practice After Pancreatic Resection. a Nationwide Stepped-Wedge Cluster Randomized Trial

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Neoplasms; Pancreatic Cancer; Pancreatic Diseases; Pancreatitis
• Intervention / Treatment: Other: Best practice algorithm for postoperative care

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 Type: Interventional
• Enrollment (Anticipated): 1600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jasmijn Smits, MD; Phone Number: +31887571207; Email: porsch@dpcg.nl
• Study Contact Backup: Name: Hjalmar C van Santvoort, MD, PhD; Phone Number: +31887556489; Email: h.vansantvoort@umcutrecht.nl

Study Locations

• Netherlands
  • 's Hertogenbosch, Netherlands
    • Recruiting
    • Jeroen Bosch Ziekenhuis
  • Amsterdam, Netherlands
    • Recruiting
    • Academic Medical Center
  • Amsterdam, Netherlands
    • Recruiting
    • Onze Lieve Vrouwen Gasthuis
  • Amsterdam, Netherlands
    • Recruiting
    • VUMC
  • Breda, Netherlands
    • Recruiting
    • Amphia Ziekenhuis
    • Contact: Jennifer Schreinemakers
  • Delft, Netherlands
    • Recruiting
    • Reinier de Graaf Gasthuis
    • Contact: Daphne Roos
  • Eindhoven, Netherlands
    • Recruiting
    • Catharina Ziekenhuis
  • Enschede, Netherlands
    • Recruiting
    • Medisch Spectrum Twente
  • Groningen, Netherlands
    • Recruiting
    • UMCG
  • Heerenveen, Netherlands
    • Recruiting
    • Tjongerschans
  • Leiden, Netherlands
    • Recruiting
    • LUMC
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht UMC
    • Contact: Ronald van Dam
  • Nijmegen, Netherlands
    • Recruiting
    • Radboud UMC
    • Contact: Marion van der Kolk
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC
    • Contact: Casper van Eijck
  • Rotterdam, Netherlands
    • Recruiting
    • Maasstad Ziekenhuis
    • Contact: Erwin van der Harst
  • Utrecht, Netherlands
    • Recruiting
    • RAKU (St. Antonius ziekenhuis & UMC Utrecht)
  • Zwolle, Netherlands
    • Recruiting
    • Isala Klinieken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite primary endpoint	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	90 days after index pancreatic resection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative mortality	Measured as rate of death at 90-day follow-up	90 days after index pancreatic resection
New-onset organ failure	Measured as organ failure occuring any time within 90 days after resection, not present at time of index pancreatic resection.	90 days after index pancreatic resection
Late postpancreatectomy bleeding	Defined in accordance to the International Study Group on Pancreatic Surgery (ISGPS) definition as bleeding occurring any time after 24 hours after pancreatic resection.	90 days after index pancreatic resection
Postoperative morbidity	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).	90 days after index pancreatic resection
Adjuvant chemotherapy	Measured as number of patients receiving adjuvant chemotherapy at 90-day follow-up	90 days after index pancreatic resection
Success of implementation	Measured as number of patients in whom the algorithm was not followed and timing of abdominal CT scans in both strategies.	90 days after index pancreatic resection
Cost-effectiveness	Calculated by comparing health effects and medical costs related to both strategies up to 90 days after pancreatic resection.	90 days after index pancreatic resection

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Collaborators: Dutch Cancer Society
• Investigators: Principal Investigator: Quintus Molenaar, MD, PhD, UMC Utrecht; Principal Investigator: Hjalmar C van Santvoort, MD, PhD, St. Antonius Ziekenhuis

Publications and helpful links

General Publications

• Smits FJ, Molenaar IQ, Besselink MG, Busch OR, van Eijck CH, van Santvoort HC; Dutch Pancreatic Cancer Group. Management of postoperative pancreatic fistula after pancreatoduodenectomy: high mortality after completion pancreatectomy: Reply to: Bressan et al. completion pancreatectomy in the acute management of pancreatic fistula after pancreaticoduodenectomy. HPB (Oxford). 2018 Dec;20(12):1223. doi: 10.1016/j.hpb.2018.05.015. Epub 2018 Jun 22. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 8, 2018
• Primary Completion (ANTICIPATED): November 9, 2019
• Study Completion (ANTICIPATED): February 9, 2020

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (ACTUAL): January 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Postoperative pancreatic fistula; Pancreatic resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Neoplasms; Pancreatitis; Pancreatic Diseases
• Other Study ID Numbers: W17.057; UU2017-8272 (OTHER_GRANT: Dutch Cancer Society (KWF))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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)
• IPD Sharing Time Frame: Upon request
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No