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Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD

RECRUITINGSponsored by Minia University
Actively Recruiting
SponsorMinia University
Started2025-09-01
Est. completion2026-09-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

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 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.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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)

Conditions3

CancerPancreatic FistulaPancreatic Neoplasms

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