Validation of pancreatic fistula risk prediction models after distal pancreatectomy
DISPAIR Vs. D-FRS - Establishing the Superiority of the Novel Distal Pancreatectomy Pancreatic Fistula Risk Prediction Models - a Multicenter International Retrospective Validation Study
This study is testing two different methods to see which one better predicts the risk of complications like pancreatic fistula after surgery to remove part of the pancreas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT05737875 on ClinicalTrials.gov |
What this trial studies
This study aims to validate and compare two recently developed risk prediction models for postoperative pancreatic fistula following distal pancreatectomy. The models, DISPAIR and D-FRS, utilize specific preoperative variables to assess risk and were previously validated in separate cohorts. By analyzing a multicenter retrospective cohort, the study seeks to determine which model is superior in predicting complications, thereby improving patient outcomes. The research will involve data from multiple institutions to enhance the robustness of the findings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 99 who have undergone distal pancreatectomy since January 1, 2020.
Not a fit: Patients who are under 18 years old, over 99 years old, or have had previous pancreatic surgery prior to the distal pancreatectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate risk assessments for patients undergoing distal pancreatectomy, potentially reducing postoperative complications.
How similar studies have performed: Other studies have shown success with similar risk prediction models in pancreatic surgery, indicating a promising avenue for this research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edinburgh
- NHS Lothian — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Stephen J Wigmore, MD FRCSED — University of Edinburgh
- Study coordinator: Ville Sallinen, MD PhD
- Email: ville.sallinen@helsinki.fi
- Phone: +358-9-4711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.