Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD
Recruiting now
Conditions studied: Pancreatic Neoplasms, Pancreatic Fistula
In brief
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.
Key facts
- Study ID
- NCT07139236
- Run by
- Minia University
- People needed
- 100
- Starts
- 2025-09-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2025-09-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Liver and GIT hospital / Minia university — Minya, Minya Governorate, Egypt (enrolling)
Full record on ClinicalTrials.gov
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