Distal Pancreatectomy Pancreatic Fistula Risk Prediction Model Validation Study (DPFValid)

July 2, 2025 updated by: University of Edinburgh

DISPAIR vs. D-FRS - Establishing the Superiority of the Novel Distal Pancreatectomy Pancreatic Fistula Risk Prediction Models - A Multicenter International Retrospective Validation Study

Distal pancreas resection is a relatively rare procedure with a known risk of postoperative pancreatic fistula. Until quite recently, no valid risk prediction models for this have been available. In 2022 two different risk scores DISPAIR and D-FRS were published. The aim of this study is to compare, validate and possibly improve those scores in a international retrospective multicenter cohort.

Study Overview

Status

Completed

Conditions

Detailed Description

Fistula Risk Score (FRS) and its derivatives have been utilized in research surrounding pancreatoduodenectomy (Callery 2013, Mungroop 2019 & 2021). Distal pancreatectomy is a rare procedure, with typically less than 20 procedures a year performed by a large hepatopancreatobiliary surgery centre. A prediction model for pancreatic fistula after distal pancreatectomy had long been warranted and Ecker et al. were the closest at acquiring this in their 2019 study with over two thousand patients (Ecker 2019). However, not enough strongly associated variables were identified in their study to develop a prediction model. Very recently, two distinct models - the DISPAIR (Bonsdorff 2022) and the D-FRS (De Pastena 2022) - which both included pancreas-specific anthropometric measurements, were developed and validated. No studies comparing the performance of these models have been conducted and thus superiority of one model over other hasn't been established.

The DISPAIR relies on three preoperative variables: pancreatic thickness at the intended transection plane measured from preoperative CT-scans, site of transection (neck vs. body/tail) and history of diabetes. It was developed in 266 patients undergoing DP in Finland and externally validated with 402 patients from Sweden. It showed good discrimination and adequate calibration upon external validation with area under the curve (AUC) of 0.80, calibration intercept of 0.19 and slope of 0.72. The D-FRS is based on PT and main pancreatic duct (MPD) diameter at the pancreatic neck, both measured from preoperative CT-scans as well. It showed a satisfactory AUC of 0.73 after an internal-external validation procedure (Steyerberg 2016) where the development cohort of 339 patients was pooled with three distinct cohorts with a total sample size of 997 patients. Pooling validation cohort with the development cohort increases the optimism of model performance parameters, and strictly speaking does not count as a full external validation. The authors claimed D-FRS to be perfectly calibrated with a calibration intercept of 0 and slope of 1. Since this is in essence impossible, the soundness of the methodology behind the study is questionable (Van Calster 2019). Nonetheless, both models have identified similar novel risk factors for pancreatic fistula and show good potential for wider utilization.

The aim of this study is to compare and externally validate the performance of the DISPAIR and the D-FRS in a fully independent cohort of DP patients. The ultimate goal is to establish the potential superiority of one model over the other and identify directions for potential model updating.

As the DISPAIR is already externally validated we expect its performance to vary little and the AUC to set in the range of 0.75 - 0.85 in external validation cohorts. We expect to identify potential avenues of DISPAIR model updating with this external validation study. As the D-FRS has been validated with a pooled internal-external procedure it is more difficult to predict its performance but an AUC of over 0.70 would be expected.

The plan is to collect 200 patients per center, as this will give approximately 40 patients with a clinically relevant pancreatic fistula, allowing external validation and comparison of the scores center-wise also (in addition to pooled external validation and comparison).

Study Type

Observational

Enrollment (Actual)

2284

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

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

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have undergone a distal pancreatectomy

Description

Inclusion Criteria:

  • 18 to 99 years old
  • Underwent distal pancreatectomy after 1/1/2020

Exclusion Criteria:

  • Under 18 years old
  • 100 years old or older
  • Previous pancreatic surgery prior to distal pancreatectomy

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

Cohorts and Interventions

Group / Cohort
Distal pancreatectomy
Patients who have undergone a distal pancreatectomy, retrospective analysis of post pancreatectomy fistula risk factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pancreatic fistula
Time Frame: 30 days postoperatively
Postoperative pancreatic fistula
30 days postoperatively

Collaborators and Investigators

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

Sponsor

University of Edinburgh

Collaborators

Helsinki University Central Hospital
NHS Lothian, Royal Infirmary of Edinburgh

Investigators

  • Study Chair: Ville Sallinen, MD PhD, Helsinki University Hospital and University of Helsinki
  • Principal Investigator: Stephen J Wigmore, MD FRCSED, University of Edinburgh

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

Helpful Links

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)

April 7, 2023

Primary Completion (Actual)

April 6, 2025

Study Completion (Actual)

April 6, 2025

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPFValid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans for data sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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