Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy (POPF)

Minia University

Status

Enrolling

Conditions

Resectable Pancreatic Cancer

Pancreatic Fistula

Pancreas Adenocarcinoma

Periampullary Carcinoma

Periampullary Cancer

Pancreas Cancer

Pancreas Neoplasm

Treatments

Procedure: pancreaticoduodenectomy procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT07022015

1438/2025

Details and patient eligibility

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.