Preoperative EUS Elastography for Pancreatic Texture and POPF Prediction After PD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMinia University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years or older.
Pancreatic cancer (all stages eligible if resectable)
Periampullary cancer
Bile duct cancer
Disqualifiers
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.
Trial population
The study population includes adults aged 18 and older scheduled for elective pancreaticoduodenectomy (PD) for resectable pancreatic head or periampullary diseases, such as pancreatic cancer, periampullary cancer, distal bile duct cancer and duodenal cancer. Patients must be medically fit for major surgery, with adequate organ function and physiological reserve, based on clinical and anesthesiology assessments. Exclusions apply to those with distant metastases, locally advanced unresectable tumors, prior pancreatic surgery, or chronic pancreatitis to avoid confounding tissue assessment. Patients often present with symptoms like jaundice or abdominal discomfort and are managed in specialized pancreatic centers with multidisciplinary care. This cohort is appropriate for evaluating preoperative endoscopic ultrasound elastography as a tool to predict intraoperative pancreatic texture and postoperative pancreatic fistula risk.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)
Procedure/SurgeryAll 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Preoperative Endoscopic Ultrasound Elastography (EUS Elastography)1 intervention
Trial outcomes
Primary outcomes
1
Accuracy of preoperative EUS elastography in predicting intraoperative pancreatic texture (soft vs. hard).
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.
Time frame
Intraoperative at the time of pancreaticoduodenectomy (for tactile assessment) and pre-operative (for EUS-E).Secondary outcomes
1
Incidence of Postoperative Pancreatic Fistula (POPF)
Occurrence of POPF classified by the International Study Group on Pancreatic Fistula (ISGPF) grading system (Grades A, B, and C) within 30 days after pancreaticoduodenectomy.
Time frame
Up to 30 days post-surgery.2
Correlation between EUS Elastography Parameters and POPF Severity.
Relationship between quantitative EUS-E parameters and the incidence and severity of POPF.
Time frame
Preoperative (EUS-E) and postoperative (POPF) evaluated within 30 days post-surgery.Sponsors and contacts
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Source ClinicalTrials.gov