Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy

Recruiting now · Not applicable

Conditions studied: Pancreas Cancer, Pancreas Neoplasm, Pancreatic Fistula, Pancreas Adenocarcinoma, Periampullary Cancer, Periampullary Carcinoma, Resectable Pancreatic Cancer

In brief

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.

Key facts

Study ID: NCT07022015
Run by: Minia University
People needed: 100
Starts: 2025-06-20
Expected to finish: 2026-10-20
Last updated by the study team: 2026-07-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Liver and GIT hospital , Minia University — Minya, Egypt (enrolling)

Full record on ClinicalTrials.gov

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