Predicting pancreatic fistula after pancreaticoduodenectomy
Predictive Risk Factors for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Malignancy.
This project will try to find which before-, during-, and after-surgery factors predict clinically significant pancreatic fistula in adults having pancreaticoduodenectomy for pancreatic or periampullary tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07022015 on ClinicalTrials.gov |
What this trial studies
This single-center interventional cohort will include about 100 adults undergoing pancreaticoduodenectomy at the Liver and GIT Hospital, Minia University between 2025 and 2026. Investigators will collect preoperative, intraoperative, and postoperative clinical and surgical variables and monitor patients for clinically relevant postoperative pancreatic fistula (CR-POPF). Data will be analyzed with descriptive statistics and multivariable modeling to identify independent predictors of CR-POPF. Findings will be used to refine risk stratification and perioperative management pathways at the center.
Who should consider this trial
Good fit: Adults over 18 with resectable tumors of the pancreatic head or periampullary region, ASA I–II, no distant metastasis, and planned for pancreaticoduodenectomy at Minia University are eligible.
Not a fit: Patients with unresectable disease, distant metastases, high surgical risk, pregnancy, serious mental disorders, or those who do not undergo pancreaticoduodenectomy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify high-risk patients and tailor perioperative care to reduce pancreatic fistula rates and related complications.
How similar studies have performed: Similar predictive approaches and fistula risk scoring systems have previously identified predictors of postoperative pancreatic fistula, so this study expands on established methods rather than testing a wholly novel concept.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas. * Patients meeting the curative treatment intent in accordance with clinical guidelines: * No evidence of metastasis. * Radiological non-involvement of superior mesenteric vein \& portal vein. * American Society of Anesthesiologists (ASA) scores I \& II. * Patients aged \> 18 years. * Ability to understand and the willingness to sign a written informed consent document * Agreement to complete the study Exclusion Criteria: * Unfit patients for surgery due to severe medical illness. * Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs. * Irresectable tumors in diagnostic laparoscopy. * History of other malignant disease. * Pregnant or breast-feeding women. * Patients with serious mental disorders. * Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team according to abdominal imaging data. * Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis * Patients refused to participate in the study.
Where this trial is running
Minya, Minya Governorate
- Liver and GIT hospital , Minia University — Minya, Minya Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Saleh K Saleh, MD — Minia University
- Study coordinator: Saleh K Saleh, MD
- Email: salehkhairy@mu.edu.eg
- Phone: 01201765401
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.