Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy

Launched by MINIA UNIVERSITY · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the risk factors that may lead to a complication called a postoperative pancreatic fistula (POPF) after a surgery known as pancreaticoduodenectomy (PD). This surgery is often performed on patients with certain types of pancreatic cancer or tumors near the pancreas. The researchers want to identify factors that could help predict which patients are more likely to experience this complication, which can be serious and affect recovery. The trial aims to include about 100 participants who will undergo this surgery between 2025 and 2026.

To be eligible for the study, participants must be at least 18 years old and have specific types of operable pancreatic or periampullary cancers, with no signs of cancer spreading to other areas. They should be in good overall health, as determined by medical guidelines. Participants will need to provide informed consent, meaning they agree to take part in the study after understanding what it involves. Throughout the trial, participants can expect regular follow-up to monitor their recovery and any complications that arise. This research is important as it may help improve surgical outcomes and patient care in the future.

Gender

ALL

Eligibility 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.