Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.

No evidence of metastasis.

Radiological non-involvement of superior mesenteric vein & portal vein.

American Society of Anesthesiologists (ASA) scores I & II.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • pancreaticoduodenectomy procedure

    Procedure/Surgery

    Pancreaticoduodenectomy operation

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Clinically relevant postoperative pancreatic fistulaOther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of clinically relevant post operative pancreatic fistula

A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day

Time frame
10 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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