Status:
RECRUITING
Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD
Lead Sponsor:
Minia University
Conditions:
Pancreatic Neoplasms
Pancreatic Fistula
Eligibility:
All Genders
18-75 years
Brief Summary
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 10...
Detailed Description
Pancreaticoduodenectomy is a complex surgery with significant morbidity, primarily due to postoperative pancreatic fistula (POPF). Soft pancreatic texture is a major risk factor for POPF. Endoscopic u...
Eligibility Criteria
Inclusion
- Adult patients aged 18 years or older.
- Patients scheduled for elective pancreaticoduodenectomy (PD) due to pancreatic head or periampullary disease, including but not limited to:
- Pancreatic cancer (all stages eligible if resectable)
- Periampullary cancer
- Bile duct cancer
- Duodenal cancer
- Patients deemed suitable for PD by the multidisciplinary pancreatic surgery team based on preoperative imaging and clinical evaluation.
- Adequate organ function and physiological reserve to undergo major abdominal surgery, as determined by clinical assessment and anesthesiology evaluation.
- Ability to provide written informed consent and comply with study procedures.
Exclusion
- Evidence of distant metastases or locally advanced unresectable disease on preoperative imaging or clinical evaluation (e.g., liver metastases, peritoneal carcinomatosis, involvement of major vessels beyond resectability).
- Previous pancreatic surgery or total pancreatectomy.
- Chronic pancreatitis confirmed by clinical, radiological, or histological criteria that could confound pancreatic stiffness assessment.
- Severe comorbidities or American Society of Anesthesiologists (ASA) physical status classification IV or higher, making the patient unfit for surgery.
- Preoperative serum albumin less than 2.5 g/dL, indicating severe malnutrition.
- Patients undergoing neoadjuvant chemotherapy or radiotherapy prior to surgery.
- Pregnancy or lactation.
- Contraindications to EUS (e.g., esophageal obstruction)
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07139236
Start Date
September 1 2025
End Date
October 1 2026
Last Update
September 3 2025
Active Locations (1)
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1
Liver and GIT hospital / Minia university
Minya, Minya Governorate, Egypt, 61519