CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Multi-Detector CT angiography +1 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05304572
NCT05304572N/ACompleted

Interobserver Agreement of Determination of Hepatocellular Carcinoma Feeding Vessels : Multi-Detector CT Angiography With 3D Reconstruction Versus Digital Subtraction Angiography

Assiut University·observational·Posted Mar 31, 2022·Updated Jun 15, 2023

In Brief

An observational study evaluating Multi-Detector CT angiography and Trans-arterial chemoembolization and DSA for Hepatocellular Carcinoma. Completed, enrolled 70 participants across 1 site.

Detailed Summary

This study aims to investigate the feasibility and accuracy of Multi-Detector CT angiography acquired before Trans-arterial Chemo-embolization (TACE) in detecting Hepato-cellular carcinoma feeding vessels compared to DSA angiography acquired during TACE.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 31, 2022
Enrollment StartMay 1, 2022
Primary CompletionMay 1, 2023
Study CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 4.3 years ago

Interventions

Multi-Detector CT angiographyother

Multiphasic CT within 4 weeks interval prior to TACE will be done including non-enhanced, arterial, portal and venous phases using IV bolus injection of a 75-100-mLiodinated contrast material iopamidol at a rate of 3.0 mL/s. The images of arterial phase will be transferred to workstation to produce 3D angiographic reconstruction images .

Trans-arterial chemoembolization and DSAprocedure

Percutaneous arterial access is achieved through the common femoral artery (19 G needle) under local anesthesia with placement of a 5-Fr sheath. A 5-Fr Cobra (C2) or sidewinder (SIM1) catheter was used for catheterizing the coeliac trunk and SMA. Then celiac and superior mesenteric angiography was done by injecting 24 mL of iopamidol using forced manual injection method or using a pump at a rate of 6 mL/s according to the operator preferences.Then a microcatheter was used for selective and super-selective access of the hepatic arteries. The micro-catheter was placed in the feeding artery as close as possible to the tumor.The chemotherapeutic drugs (Doxorubicin 50 mg) solved within 5 ml of iodinated non-ionic contrast media and then mixed with 10 ml of iodized oil (lipiodol) will be delivered through the feeding hepatic artery and then embolized using Poly-vinyl Alcohol (PVA) particles.