Pre-surgery EUS elastography to predict pancreatic texture and leak risk after the Whipple
Preoperative Endoscopic Ultrasound Elastography for Prediction of Intraoperative Pancreatic Texture and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Study
This will test whether a preoperative endoscopic ultrasound elastography scan can predict pancreatic texture and the chance of a pancreatic leak in people having a Whipple (pancreaticoduodenectomy).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Minia University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Minya, Minya Governorate) |
| Trial ID | NCT07139236 on ClinicalTrials.gov |
What this trial studies
This prospective observational study will enroll 100 adults scheduled for elective pancreaticoduodenectomy. Each participant will have preoperative endoscopic ultrasound elastography (EUS-E) to measure pancreatic stiffness before surgery. Surgeons blinded to the EUS-E results will record intraoperative pancreatic texture as “soft” or “hard,” and postoperative pancreatic fistula (POPF) will be graded using ISGPF criteria. The study will use ROC curve analysis and regression models to test how well EUS-E predicts surgical texture and the occurrence and severity of POPF.
Who should consider this trial
Good fit: Adults aged 18 or older who are scheduled for elective pancreaticoduodenectomy for resectable pancreatic head or periampullary disease and who are fit for major abdominal surgery are ideal candidates.
Not a fit: Patients with distant metastases, locally unresectable disease, prior pancreatic surgery, or those not undergoing a Whipple procedure are unlikely to benefit from this test.
Why it matters
Potential benefit: If successful, EUS elastography could allow surgeons to identify patients at higher risk of pancreatic leak before surgery and tailor surgical technique or perioperative care to reduce complications.
How similar studies have performed: Small prior studies have shown elastography correlates with tissue stiffness, but its accuracy specifically for predicting POPF after pancreaticoduodenectomy is not yet well established.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Minya, Minya Governorate
- Liver and GIT hospital / Minia university — Minya, Minya Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Saleh K Saleh, MD — Minia University
- Study coordinator: Saleh K Saleh, MD
- Email: salehkhairy@mu.edu.eg
- Phone: 01201765401
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.