NCT07139236 Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD
| NCT ID | NCT07139236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Minia University |
| Condition | Pancreatic Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Saleh K Saleh, MD
PRINCIPAL INVESTIGATOR
Minia University
Frequently Asked Questions
Who can join the NCT07139236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07139236 currently recruiting?
Yes, NCT07139236 is actively recruiting participants. Contact the research team at salehkhairy@mu.edu.eg for enrollment information.
Where is the NCT07139236 trial being conducted?
This trial is being conducted at Minya, Egypt.
Who is sponsoring the NCT07139236 clinical trial?
NCT07139236 is sponsored by Minia University. The principal investigator is Saleh K Saleh, MD at Minia University. The trial plans to enroll 100 participants.