Predicting pancreatic fistula after pancreaticoduodenectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Liver and GIT hospital , Minia University
  Minya, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.