Actively Recruiting
Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD
Led by Minia University · Updated on 2025-09-03
100
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective study evaluates whether preoperative endoscopic ultrasound elastography (EUS-E) can predict pancreatic texture during surgery and risk of postoperative pancreatic fistula (POPF) in 100 patients undergoing pancreaticoduodenectomy. EUS-E measures pancreatic stiffness preoperatively. Intraoperative texture ("soft" or "hard") is assessed by surgeons blinded to EUS-E results. POPF is graded using ISGPF criteria. Predictive accuracy of EUS-E will be analyzed statistically.
CONDITIONS
Official Title
Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Patients scheduled for elective pancreaticoduodenectomy (PD) due to pancreatic head or periampullary disease, including pancreatic cancer, periampullary cancer, bile duct cancer, or duodenal cancer
- Patients deemed suitable for PD by the multidisciplinary pancreatic surgery team based on imaging and clinical evaluation
- Adequate organ function and physiological reserve to undergo major abdominal surgery
- Ability to provide written informed consent and comply with study procedures
You will not qualify if you...
- Evidence of distant metastases or locally advanced unresectable disease on imaging or clinical evaluation
- Previous pancreatic surgery or total pancreatectomy
- Chronic pancreatitis confirmed by clinical, radiological, or histological criteria
- Severe comorbidities or ASA physical status classification IV or higher
- Preoperative serum albumin less than 2.5 g/dL
- Patients undergoing neoadjuvant chemotherapy or radiotherapy prior to surgery
- Pregnancy or lactation
- Contraindications to endoscopic ultrasound (e.g., esophageal obstruction)
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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
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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