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Completed
NCT05687825
Risk Factors for Clinically Relevant Postoperative Pancreatic Fistula
Conditions: Pancreatic Fistula
Sex: All
Ages: 20 Years – 80 Years
Enrollment: 107
Sponsor: South Valley University
Location: Egypt
Summary
Pancreaticoduodenectomy (PD) procedure is one of the standard treatments for benign and malignant diseases of the periampullary region and head of the pancreas.
However, PD is still technically challenging and has significant rates of morbidity (up to 50%) and mortality (up to 5%).
Currently, postoperative pancreatic fistula (POPF) represents the most critical and life-threatening complication after PD with reported incidences of total POPF from 2-60% and for clinically relevant (CR)-POPF from 5-40%.
CR-POPF results in abdominal abscess, delayed gastric emptying, pseudoaneurysms, and bleeding which have been linked to a mortality rate of 40% or higher.
Also, it is associated with increased hospital admission, healthcare costs, and several reinterventions, resulting in poor quality of patient life.
The aim of this study was to identify the operative risk factors for CR-POPF post-PD.
Eligibility Criteria
Inclusion Criteria:Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.American Society of Anesthesiologists (ASA) scores I & II.Patients aged > 20 years.Agreement to complete the study.Exclusion Criteria:Patients with benign disease, trauma, and receive neoadjuvant therapy.double primary cancers.
Source: ClinicalTrials.gov (NCT05687825). StuddyBuddy aggregates publicly available trial information.