Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Fistula | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative Endoscopic Ultrasound Elastography (EUS Elastography) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)
- description
- Patients undergoing elective pancreaticoduodenectomy (PD) who will receive preoperative endoscopic ultrasound elastography (EUS elastography) evaluation.
- interventionNames
- Procedure: Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)
Primary outcomes (1)
- measure
- Accuracy of preoperative EUS elastography in predicting intraoperative pancreatic texture (soft vs. hard).
- timeFrame
- Intraoperative at the time of pancreaticoduodenectomy (for tactile assessment) and pre-operative (for EUS-E).
- description
- 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.
Secondary outcomes (2)
- measure
- Incidence of Postoperative Pancreatic Fistula (POPF)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (0)
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