NCT07139236

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Minia University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not 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.

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 ultrasound elastography (EUS-E) is a promising tool for assessing tissue stiffness. This study will prospectively enroll patients undergoing PD. Preoperative EUS-E will be performed, and intraoperative pancreatic texture will be assessed by the surgeon. Postoperative outcomes, especially POPF, will be meticulously recorded. The study will analyze the diagnostic accuracy of EUS-E for pancreatic texture, its correlation with POPF severity,, as well as the impact on patient outcomes. Data will be collected from medical records, EUS reports, surgical notes, and pathology reports, with strict quality control and confidentiality measures. Statistical analysis will include Receiver Operating Characteristic (ROC) curve analysis for accuracy, and regression analyses to identify predictors and assess impact on outcomes. In this study, blinding (masking) is implemented as follows: * Surgeons are blinded to the results of the preoperative endoscopic ultrasound (EUS) elastography. They do not have access to the pancreatic stiffness measurements before or during surgery, ensuring their intraoperative assessment of pancreatic texture remains unbiased. * Outcome assessors-those evaluating postoperative pancreatic fistula (POPF) and other clinical outcomes-are also blinded to both the preoperative elastography results and the intraoperative texture assessment. This reduces the risk of detection bias when determining study endpoints.

Conditions

• Pancreatic Neoplasms
• Pancreatic Fistula

Interventions

Type	Name	Description
PROCEDURE	Preoperative 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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2025-08-24
• Last updated: 2025-09-03

Locations

1 site across 1 country: Egypt