MedTrace Logo

Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD

NCT07139236 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-09-03

No results posted yet for this study

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.

Conditions

  • Pancreatic Neoplasms
  • Pancreatic Fistula

Interventions

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.

Sponsors & Collaborators

  • Minia University

    lead OTHER

Principal Investigators

  • Saleh K Saleh, MD · Minia University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-01
Completion
2026-10-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07139236 on ClinicalTrials.gov