Actively Recruiting
Predictive Risk Factors for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Malignancy
Led by Minia University · Updated on 2025-06-22
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pancreaticoduodenectomy (PD) is a complex surgery performed on patients with malignant or benign tumors in the pancreatic head and nearby areas. This procedure carries high risks of complications and death. The study focuses on identifying factors that predict a serious complication called clinically relevant postoperative pancreatic fistula (CR-POPF) occurring after PD. Researchers aim to understand these risks during the preoperative, intraoperative, and postoperative stages in patients who have undergone PD between 2025 and 2026. The study involves patients who have undergone the pancreaticoduodenectomy operation. Researchers will observe patients who develop clinically relevant postoperative pancreatic fistula following PD. This observational period will help determine which factors contribute to the occurrence of this complication. The study expects to include 100 participants receiving surgical treatment for tumors in the pancreatic head and periampullary region. Participants will be monitored for the incidence of clinically relevant postoperative pancreatic fistula within 10 days after surgery. Assessments will include evaluating patient condition before, during, and after surgery to identify predictive risk factors. The study will collect and analyze data related to complications, with the goal of improving treatment decisions and reducing mortality associated with PD. The trial is sponsored by Minia University and runs from June 2025 to July 2026.
CONDITIONS
Brief 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 the curative treatment intent in accordance with clinical guidelines 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 document
- Agreement to complete the study
You will not qualify if you...
- 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 found in diagnostic laparoscopy
- History of other malignant disease
- Pregnant or breast-feeding women
- Patients with serious mental disorders
- Patients with vascular invasion requiring vascular resection as evaluated by abdominal imaging
- Pancreaticoduodenectomy performed for diagnoses other than those specified, such as cystic lesions, benign tumors, or chronic calcific pancreatitis
- Patients who refuse to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration as per clinical practice
Participants undergo pancreaticoduodenectomy surgery and receive immediate post-operative care to monitor for complications.
1 surgical procedure with inpatient care
Duration - 10 days
Participants are monitored for clinically relevant postoperative pancreatic fistula and other complications following surgery.
Daily visits or assessments during hospital stay
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
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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