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

Pancreatic Cancer Clinical Trial

— PORSCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03400280
• Other study ID #: W17.057
• Secondary ID: UU2017-8272
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: February 9, 2020

Study information

• Verified date: June 2019
• Source: St. Antonius Hospital
• Contact: Jasmijn Smits, MD
• Phone: +31887571207
• Email: porsch[@]dpcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: February 9, 2020
• Est. primary completion date: November 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Diseases
• Pancreatic Neoplasms
• Pancreatitis

Intervention

Other:
• Best practice algorithm for postoperative care
See arm/group description

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Ziekenhuis	's Hertogenbosch
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Onze Lieve Vrouwen Gasthuis	Amsterdam
Netherlands	VUmc	Amsterdam
Netherlands	Amphia ziekenhuis	Breda
Netherlands	Reinier de Graaf gasthuis	Delft
Netherlands	Catharina ziekenhuis	Eindhoven
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	UMCG	Groningen
Netherlands	Tjongerschans	Heerenveen
Netherlands	LUMC	Leiden
Netherlands	Maastricht UMC	Maastricht
Netherlands	Radboud UMC	Nijmegen
Netherlands	Erasmus MC	Rotterdam
Netherlands	Maasstad ziekenhuis	Rotterdam
Netherlands	RAKU (St. Antonius ziekenhuis & UMC Utrecht)	Utrecht
Netherlands	Isala klinieken	Zwolle

Sponsors (2)

Lead Sponsor	Collaborator
St. Antonius Hospital	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative mortality	Measured as rate of death at 90-day follow-up	90 days after index pancreatic resection
Secondary	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
Secondary	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
Secondary	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
Secondary	Adjuvant chemotherapy	Measured as number of patients receiving adjuvant chemotherapy at 90-day follow-up	90 days after index pancreatic resection
Secondary	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
Secondary	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