Menu
Recruiting NCT07022015

Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy

No phase Interventional Pancreas Cancer Pancreas Neoplasm Pancreatic Fistula Pancreas Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pancreaticoduodenectomy procedure.
Who it may be relevant to
Registry conditions: Pancreas Cancer, Pancreas Neoplasm, Pancreatic Fistula, Pancreas Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Predictive Risk Factors for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Malignancy.

Overview

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.

Detailed 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.

Interventions

  • Procedure pancreaticoduodenectomy procedure
    Pancreaticoduodenectomy operation

Primary outcome measures

  • Incidence of clinically relevant post operative pancreatic fistula [Time frame: 10 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Liver and GIT hospital , Minia University — Minya

Identifiers

NCT: NCT07022015 · 1438/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗