Pancreatic FistulaDPFValidNCT05737875
Distal Pancreatectomy Pancreatic Fistula Risk Prediction Model Validation Study
An observational study of Pancreatic Fistula and Pancreatectomy, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreatic Fistula, Pancreatectomy
- How many people
- 2,284 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Apr 2023to 6 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone a distal pancreatectomy
Who may be able to join
- 18 to 99 years old
- Underwent distal pancreatectomy after 1/1/2020
Who cannot join
- Under 18 years old
- 100 years old or older
- Previous pancreatic surgery prior to distal pancreatectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Pancreatic Fistula, Pancreatectomy
- Medical subject headings
- Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Distal pancreatectomy | Patients who have undergone a distal pancreatectomy, retrospective analysis of post pancreatectomy fistula risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pancreatic fistula
Postoperative pancreatic fistula
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start7 Apr 2023
- Primary completion6 Apr 2025
- Study completion6 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pancreatic FistulaStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,284 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, NHS Lothian, Royal Infirmary of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Ville Sallinen, MD PhD, Study chair, Helsinki University Hospital and University of HelsinkiStephen J Wigmore, MD FRCSED, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737875
- Sponsor's protocol ID
- DPFValid
- Acronym
- DPFValid
- Status last verified
- Jun 2025
- First submitted
- 10 Feb 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans for data sharing
Publications
Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.
PubMed 23122535Mungroop TH, van Rijssen LB, van Klaveren D, Smits FJ, van Woerden V, Linnemann RJ, de Pastena M, Klompmaker S, Marchegiani G, Ecker BL, van Dieren S, Bonsing B, Busch OR, van Dam RM, Erdmann J, van Eijck CH, Gerhards MF, van Goor H, van der Harst E, de Hingh IH, de Jong KP, Kazemier G, Luyer M, Shamali A, Barbaro S, Armstrong T, Takhar A, Hamady Z, Klaase J, Lips DJ, Molenaar IQ, Nieuwenhuijs VB, Rupert C, van Santvoort HC, Scheepers JJ, van der Schelling GP, Bassi C, Vollmer CM, Steyerberg EW, Abu Hilal M, Groot Koerkamp B, Besselink MG; Dutch Pancreatic Cancer Group. Alternative Fistula Risk Score for Pancreatoduodenectomy (a-FRS): Design and International External Validation. Ann Surg. 2019 May;269(5):937-943. doi: 10.1097/SLA.0000000000002620.
PubMed 29240007Mungroop TH, Klompmaker S, Wellner UF, Steyerberg EW, Coratti A, D'Hondt M, de Pastena M, Dokmak S, Khatkov I, Saint-Marc O, Wittel U, Abu Hilal M, Fuks D, Poves I, Keck T, Boggi U, Besselink MG; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Updated Alternative Fistula Risk Score (ua-FRS) to Include Minimally Invasive Pancreatoduodenectomy: Pan-European Validation. Ann Surg. 2021 Feb 1;273(2):334-340. doi: 10.1097/SLA.0000000000003234.
PubMed 30829699Ecker BL, McMillan MT, Allegrini V, Bassi C, Beane JD, Beckman RM, Behrman SW, Dickson EJ, Callery MP, Christein JD, Drebin JA, Hollis RH, House MG, Jamieson NB, Javed AA, Kent TS, Kluger MD, Kowalsky SJ, Maggino L, Malleo G, Valero V 3rd, Velu LKP, Watkins AA, Wolfgang CL, Zureikat AH, Vollmer CM Jr. Risk Factors and Mitigation Strategies for Pancreatic Fistula After Distal Pancreatectomy: Analysis of 2026 Resections From the International, Multi-institutional Distal Pancreatectomy Study Group. Ann Surg. 2019 Jan;269(1):143-149. doi: 10.1097/SLA.0000000000002491.
PubMed 28857813De Pastena M, van Bodegraven EA, Mungroop TH, Vissers FL, Jones LR, Marchegiani G, Balduzzi A, Klompmaker S, Paiella S, Tavakoli Rad S, Groot Koerkamp B, van Eijck C, Busch OR, de Hingh I, Luyer M, Barnhill C, Seykora T, Maxwell T T, de Rooij T, Tuveri M, Malleo G, Esposito A, Landoni L, Casetti L, Alseidi A, Salvia R, Steyerberg EW, Abu Hilal M, Vollmer CM, Besselink MG, Bassi C. Distal Pancreatectomy Fistula Risk Score (D-FRS): Development and International Validation. Ann Surg. 2023 May 1;277(5):e1099-e1105. doi: 10.1097/SLA.0000000000005497. Epub 2022 Jul 7.
PubMed 35797608Steyerberg EW, Harrell FE Jr. Prediction models need appropriate internal, internal-external, and external validation. J Clin Epidemiol. 2016 Jan;69:245-7. doi: 10.1016/j.jclinepi.2015.04.005. Epub 2015 Apr 18. No abstract available.
PubMed 25981519
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DISPAIR vs. D-FRS - Establishing the Superiority of the Novel Distal Pancreatectomy Pancreatic Fistula Risk Prediction Models - A Multicenter International Retrospective Validation Study
- ClinicalTrials.gov ID
- NCT05737875
- Acronym / sponsor ID
- DPFValid / DPFValid
- Conditions
- Pancreatic Fistula, Pancreatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,284 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, NHS Lothian, Royal Infirmary of Edinburgh
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 6 Apr 2025 (actual)
- Study completion
- 6 Apr 2025 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal pancreatectomy | – | –Patients who have undergone a distal pancreatectomy, retrospective analysis of post pancreatectomy fistula risk factors |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone a distal pancreatectomy
Key inclusion criteria (2 listed)
- 18 to 99 years old
- Underwent distal pancreatectomy after 1/1/2020
Key exclusion criteria (3 listed)
- Under 18 years old
- 100 years old or older
- Previous pancreatic surgery prior to distal pancreatectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative pancreatic fistula
Time frame: 30 days postoperatively
Postoperative pancreatic fistula
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 23122535Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.
- Background: PubMed 29240007Mungroop TH, van Rijssen LB, van Klaveren D, Smits FJ, van Woerden V, Linnemann RJ, de Pastena M, Klompmaker S, Marchegiani G, Ecker BL, van Dieren S, Bonsing B, Busch OR, van Dam RM, Erdmann J, van Eijck CH, Gerhards MF, van Goor H, van der Harst E, de Hingh IH, de Jong KP, Kazemier G, Luyer M, Shamali A, Barbaro S, Armstrong T, Takhar A, Hamady Z, Klaase J, Lips DJ, Molenaar IQ, Nieuwenhuijs VB, Rupert C, van Santvoort HC, Scheepers JJ, van der Schelling GP, Bassi C, Vollmer CM, Steyerberg EW, Abu Hilal M, Groot Koerkamp B, Besselink MG; Dutch Pancreatic Cancer Group. Alternative Fistula Risk Score for Pancreatoduodenectomy (a-FRS): Design and International External Validation. Ann Surg. 2019 May;269(5):937-943. doi: 10.1097/SLA.0000000000002620.
- Background: PubMed 30829699Mungroop TH, Klompmaker S, Wellner UF, Steyerberg EW, Coratti A, D'Hondt M, de Pastena M, Dokmak S, Khatkov I, Saint-Marc O, Wittel U, Abu Hilal M, Fuks D, Poves I, Keck T, Boggi U, Besselink MG; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Updated Alternative Fistula Risk Score (ua-FRS) to Include Minimally Invasive Pancreatoduodenectomy: Pan-European Validation. Ann Surg. 2021 Feb 1;273(2):334-340. doi: 10.1097/SLA.0000000000003234.
- Background: PubMed 28857813Ecker BL, McMillan MT, Allegrini V, Bassi C, Beane JD, Beckman RM, Behrman SW, Dickson EJ, Callery MP, Christein JD, Drebin JA, Hollis RH, House MG, Jamieson NB, Javed AA, Kent TS, Kluger MD, Kowalsky SJ, Maggino L, Malleo G, Valero V 3rd, Velu LKP, Watkins AA, Wolfgang CL, Zureikat AH, Vollmer CM Jr. Risk Factors and Mitigation Strategies for Pancreatic Fistula After Distal Pancreatectomy: Analysis of 2026 Resections From the International, Multi-institutional Distal Pancreatectomy Study Group. Ann Surg. 2019 Jan;269(1):143-149. doi: 10.1097/SLA.0000000000002491.
- Background: PubMed 35797608De Pastena M, van Bodegraven EA, Mungroop TH, Vissers FL, Jones LR, Marchegiani G, Balduzzi A, Klompmaker S, Paiella S, Tavakoli Rad S, Groot Koerkamp B, van Eijck C, Busch OR, de Hingh I, Luyer M, Barnhill C, Seykora T, Maxwell T T, de Rooij T, Tuveri M, Malleo G, Esposito A, Landoni L, Casetti L, Alseidi A, Salvia R, Steyerberg EW, Abu Hilal M, Vollmer CM, Besselink MG, Bassi C. Distal Pancreatectomy Fistula Risk Score (D-FRS): Development and International Validation. Ann Surg. 2023 May 1;277(5):e1099-e1105. doi: 10.1097/SLA.0000000000005497. Epub 2022 Jul 7.
- Background: PubMed 25981519Steyerberg EW, Harrell FE Jr. Prediction models need appropriate internal, internal-external, and external validation. J Clin Epidemiol. 2016 Jan;69:245-7. doi: 10.1016/j.jclinepi.2015.04.005. Epub 2015 Apr 18. No abstract available.
- Van Calster B, McLernon DJ, Van Smeden M, Wynants L, Steyerberg EW, Bossuyt P, et al. Calibration: The Achilles heel of predictive analytics. BMC Med. 2019;17(1):1-7.Link provided by the sponsor.
- Individual participant dataSharing planned: No. No plans for data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ville Sallinen, MD PhD study chair
Helsinki University Hospital and University of Helsinki
Stephen J Wigmore, MD FRCSED principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Fistula and Pancreatectomy, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pancreatic fistula (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05737875, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.