RecruitingNCT07139236

Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD

Preoperative Endoscopic Ultrasound Elastography for Prediction of Intraoperative Pancreatic Texture and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Study

Sponsor

Minia University

Enrollment

100 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

Pancreatic Neoplasms Pancreatic Fistula

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

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 Criteria8

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)

Interventions

PROCEDUREPreoperative Endoscopic Ultrasound Elastography (EUS Elastography)

All enrolled patients will undergo a preoperative EUS-E examination within one weeks prior to pancreaticoduodenectomy. The EUS-E will be performed by experienced endosonographers using a radial or linear array echoendoscope connected to a compatible ultrasound processor. Both qualitative (color mapping) and quantitative (strain ratio, strain histogram) data will be obtained. Multiple measurements of the strain ratio will be taken from a region of interest within the pancreatic parenchyma adjacent to the lesion. The mean strain ratio will be recorded for analysis. Standard EUS imaging will also be recorded. Standard pancreaticoduodenectomy will be performed . Intraoperative pancreatic texture will be subjectively assessed by the surgeon and recorded. Postoperative monitoring for pancreatic fistula will follow established clinical guidelines.