Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy
Recruiting · NCT07022015 · Interventional (participants receive a specific treatment) · Lead sponsor: Minia University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Liver and GIT hospital , Minia University - Minya, Egypt