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

Plain Language Summary

Simplified for easier understanding

This study is investigating whether an ultrasound-based technique called EUS elastography — done before surgery — can predict how firm or soft the pancreas will be during a pancreatic operation (called a Whipple procedure). The firmness of the pancreas affects how difficult the surgery is and what complications might arise afterward. **You may be eligible if...** - You are scheduled to have a Whipple procedure (pancreaticoduodenectomy) for a condition affecting the head of the pancreas or surrounding area, such as pancreatic cancer, bile duct cancer, or duodenal cancer - Your surgical team has determined you are a good candidate for the operation based on imaging - Your organ function and overall health are adequate for major surgery **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (metastatic disease) - Your disease is not surgically removable - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.