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NCT07022015Recruiting

Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy

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

Source: ClinicalTrials.gov · Last updated 1 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
5 Jun 2025
Start date
20 Jun 2025
Primary completion date
20 Sept 2026
Lead sponsor
Minia University
NCT number
NCT07022015

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 20 Jun 2025 to the primary completion date, 20 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team according to abdominal imaging data.

Other illness

  • Unfit patients for surgery due to severe medical illness.
  • History of other malignant disease.
  • Patients with serious mental disorders.

Other

  • Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
  • Irresectable tumors in diagnostic laparoscopy.
  • Pregnant or breast-feeding women.
  • Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis
  • Patients refused to participate in the study.

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Liver and GIT hospital , Minia University
Coordinator of this site? Confirm its status
MinyaEgyptRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.