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NCT06602986
NA

Measuring the Density of Iodine in Lipiodol Depositions: Detecting an Invisible Residual Tumor After Conventional Transarterial Chemoembolization for Hepatocellular Carcinoma

Sponsor: Pak Emirates Military Hospital

View on ClinicalTrials.gov

Summary

ABSTRACT Objective: To detect presence of a residual tumor in patients of hepatocellular carcinoma (HCC) treated with Lipiodol based conventional trans arterial chemoembolization (cTACE) using density measurements on follow-up computed tomography (CT) scans Study Design: Prospective observational interventional study Place and Duration of Study: Interventional Radiology department of Armed Forces Institute of Radiology and Imaging (AFIRI) from April 2023-March 2024 Methodology: 96 patients undergoing conventional TACE were included in the study and followed up for residual tumor or tumor free status assessment using density measurement for iodine depositions using CT scan analysis and compared with gold standard digital subtraction angiography (DSA). Primary variables measured were comparison of enhancement scores between those with a residual tumor versus tumor free as well as the volume of iodine depositions in the arterial and venous phase between both groups. Sensitivity and specificity of the CT scan in assessing tumor diagnosis was compared with the gold standard digital subtraction angiography.

Key Details

Gender

All

Age Range

16 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2024-10-12

Completion Date

2025-07-13

Last Updated

2024-09-19

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

TACE

study was carried out in our setup for two major reasons. One was to decrease reliance on DSA since it is a costly investigation in our medical setups and the facility is not available except for a few centers of excellence which creates issues with treatments plan of patients admitted for treatment using TACE and subsequent follow-up visits to assess the presence or absence of HCC tumors. The mean age of patients in our treatment group was in the early sixties. This is in line with the median age of diagnosis for HCC globally as evidenced by studies done by Mc Glynn et al12 and Konyn et al13. Gender distribution was predominantly male in our study group in line with available literature14. The Child Pugh classification which quantifies severity of chronic liver disease by assessing clinical parameters was used in our study as well15. Since the inclusion criteria and procedural requirement required normal bilirubin levels, all subjects in the study protocol were in Class A16. The prima

Locations (1)

PakEmiratesMH

Rawalpindi, Punjab Province, Pakistan