Clinical trialNARecruiting
Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy
Predictive Risk Factors for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Malignancy.
- Outcome
- Ongoing
- Phase
- NA
- Status
- Recruiting
- Study type
- Interventional
- Start
- 20 June 2025
- Expected end
- 20 October 2026
- Enrollment
- 100 participants
- Sites
- 1
- Primary outcomes
- Incidence of clinically relevant post operative pancreatic fistula
- Sponsor
- Other
- Results posted
- No
- Last update
- 1 July 2026
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Brief summary public domain (ClinicalTrials.gov)
Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD. The total number of 100 participants expected to be included in this research who underwent PD between 2025 and 2026.
Detailed description public domain (ClinicalTrials.gov)
Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality rates. Despite dramatic advancements in surgical techniques and perioperative management, reported morbidity and mortality rates following PD are 41.56% and 2.88%, respectively, which remain unsatisfactory. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. Therefore, accurate and timely prediction of POPF after PD is necessary to reduce secondary mortality from serious complications and optimize individual patient treatment decisions. This study aimed to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD.