Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD

NCT ID: NCT07139236

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-10-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)

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

Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Saleh Khairy Saleh MD

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saleh K Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Liver and GIT hospital / Minia university

Minya, Minya Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Saleh K Saleh, MD

Role: CONTACT

salehkhairy@mu.edu.eg

01201765401 ext. +2

Facility Contacts

Saleh K Saleh, MD

Role: primary

salehkhairy@mu.edu.eg

01201765401 ext. +2

Other Identifiers

1378/12/2024

Identifier Type: -

Identifier Source: org_study_id