NCT07139236Completed
Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD
Preoperative Endoscopic Ultrasound Elastography for Prediction of Intraoperative Pancreatic Texture and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy: A Prospective Study
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 17 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 16 Aug 2026
- Lead sponsor
- Minia University
- Diseases
- Pancreatic cancer
- NCT number
- NCT07139236
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 1 Sept 2025 to the primary completion date, 16 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pancreatic surgery or total pancreatectomy.
- Severe comorbidities or American Society of Anesthesiologists (ASA) physical status classification IV or higher, making the patient unfit for surgery.
- Patients undergoing neoadjuvant chemotherapy or radiotherapy prior to surgery.
Other illness
- 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).
Lab values
- Preoperative serum albumin less than 2.5 g/dL, indicating severe malnutrition.
Other
- Chronic pancreatitis confirmed by clinical, radiological, or histological criteria that could confound pancreatic stiffness assessment.
- Pregnancy or lactation.
- Contraindications to EUS (e.g., esophageal obstruction)
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liver and GIT hospital , Minia University Coordinator of this site? Confirm its status | Minya | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.