Actively Recruiting
Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy
Led by Minia University · Updated on 2025-06-22
100
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.
- Patients meeting curative treatment intent with no evidence of metastasis.
- Radiological non-involvement of superior mesenteric vein and portal vein.
- American Society of Anesthesiologists (ASA) scores I and II.
- Patients aged over 18 years.
- Ability to understand and willingness to sign a written informed consent.
- Agreement to complete the study.
You will not qualify if you...
- Unfit 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 found during diagnostic laparoscopy.
- History of other malignant diseases.
- Pregnant or breastfeeding women.
- Patients with serious mental disorders.
- Patients with vascular invasion requiring vascular resection based on imaging and multidisciplinary evaluation.
- Pancreaticoduodenectomy performed for diagnoses other than specified cancers, such as cystic lesions, benign tumors, or chronic calcific pancreatitis.
- Patients who refuse to participate in the study.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Liver and GIT hospital , Minia University
Minya, Minya Governorate, Egypt, 61519
Actively Recruiting
Research Team
S
Saleh K Saleh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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