- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07424456
Comparison Between Triphasic CT Abdomen and EUS-FNB in Characterization of Pancreatic Lesion
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed Abdullah Ashmawy, Prof. Dr
- Phone Number: 01005679880
- Email: rasharma@aun.edu.eg
Study Contact Backup
- Name: Mohamed Mahdy, ProfDr
- Email: drmohhakim@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
*Adult patients (age>18 years) presenting with focal pancreatic lesions detected on initial imaging.
- Patients referred for further evaluation by triphasic CT and/or EUS-guided biopsy.
- Patients able to provide informed consent
Exclusion Criteria:
Previous pancreatic surgery.
- Known metastatic disease at presentation.
- Contraindications to contrast-enhanced CT (e.g. severe renal impairment, contrast allergy)
- Contraindications to EUS or biopsy (e.g., coagulopathy uncorrected, severe cardiopulmonary instability).
- Pregnancy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients assessed by Triphasic CT scan
Triphasic CT scan: Performed using a multidetector CT scanner and CT parameters assessed: Size, shape, and margins of the lesion Enhancement pattern (hypo / iso / hyper-enhancing) Calcifications or cystic components |
Full clinical history (pain, jaundice, weight loss, pancreatitis history).
Physical examination with focus on abdominal and systemic findings.
|
|
Patients assessed by Endoscopic Ultrasound (EUS)&Tissue Sampling
Performed using linear echoendoscope under conscious sedation or general anesthesia EUS-guided sampling Fine-needle aspiration (FNA) or fine-needle biopsy (FNB) using 19G/22G needles. Multiple passes obtained for cytology and histopathology. |
Full clinical history (pain, jaundice, weight loss, pancreatitis history).
Physical examination with focus on abdominal and systemic findings.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of triphasic CT compared to EUS-guided biopsy in differentiating benign from malignant pancreatic lesions.
Time Frame: one year
|
the diagnostic accuracy of triphasic CT compared to EUS-guided biopsy in differentiating benign and malignant pancreatic lesions, calculated in terms of sensitivity, specificity, PPV, NPV, and overall accuracy, using final histopathological diagnosis as the reference standard.
|
one year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Iglesias Garcia J, Larino Noia J, Dominguez Munoz JE. Endoscopic ultrasound in the diagnosis and staging of pancreatic cancer. Rev Esp Enferm Dig. 2009 Sep;101(9):631-8. doi: 10.4321/s1130-01082009000900006.
- Öztürk B, Ekmen N, et al. The diagnostic role of endoscopic ultrasonography, CT, and MRI in pancreatic cystic lesions. J Clin Med Kaz. 2021;18(4):71-80.
- Chen J, Sahai AV, et al. Diagnostic accuracy of endoscopic ultrasound-guided fine-needle aspiration in pancreatic tumors. BMC Gastroenterol. 2012;12:125.
- Chatterjee A, Shah J. Role of Endoscopic Ultrasound in Diagnosis of Pancreatic Ductal Adenocarcinoma. Diagnostics (Basel). 2023 Dec 28;14(1):78. doi: 10.3390/diagnostics14010078.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Triphasic CT vs EUS-FNB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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