Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD

NCT07139236 | Recruiting DMC

• 1 other identifier: 1378/12/2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pancreatic cancer; EUS; Whipple procedure; EUS-E; Pancreatic surgery; Pancreas; Elastography

Outcome Measures

Primary Outcomes (1)

• Accuracy of preoperative EUS elastography in predicting intraoperative pancreatic texture (soft vs. hard).

  Assessed by calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy of EUS-E parameters (e.g., strain ratio) against the intraoperative tactile assessment of pancreatic texture.

  Intraoperative at the time of pancreaticoduodenectomy (for tactile assessment) and pre-operative (for EUS-E).

Secondary Outcomes (2)

• Incidence of Postoperative Pancreatic Fistula (POPF)

  Up to 30 days post-surgery.

• Correlation between EUS Elastography Parameters and POPF Severity.

  Preoperative (EUS-E) and postoperative (POPF) evaluated within 30 days post-surgery.

Study Arms (1)

Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)

Patients undergoing elective pancreaticoduodenectomy (PD) who will receive preoperative endoscopic ultrasound elastography (EUS elastography) evaluation.

Procedure: Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)

Interventions

Preoperative Endoscopic Ultrasound Elastography (EUS Elastography) PROCEDURE

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.

Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adults aged 18 and older scheduled for elective pancreaticoduodenectomy (PD) for resectable pancreatic head or periampullary diseases, such as pancreatic cancer, periampullary cancer, distal bile duct cancer and duodenal cancer. Patients must be medically fit for major surgery, with adequate organ function and physiological reserve, based on clinical and anesthesiology assessments. Exclusions apply to those with distant metastases, locally advanced unresectable tumors, prior pancreatic surgery, or chronic pancreatitis to avoid confounding tissue assessment. Patients often present with symptoms like jaundice or abdominal discomfort and are managed in specialized pancreatic centers with multidisciplinary care. This cohort is appropriate for evaluating preoperative endoscopic ultrasound elastography as a tool to predict intraoperative pancreatic texture and postoperative pancreatic fistula risk.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital / Minia university

Minya, Minya Governorate, 61519, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: August 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)