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

NCT ID: NCT06602986

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-12
• Study Completion Date: 2025-07-13

Brief 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.

Conditions

HCC - Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

International study

Hepatocellular carcinoma (HCC) is associated with considerable morbidity and mortality with a high prevalence in developing countries including Pakistan1. Statistics from Pakistan indicate that the cancer is among the top five causes of cancer deaths nationally and the commonest cancer in adult males with respect to frequency of diagnosis2. Risk factors implicated in our population are chronic hepatitis B and C infection, alcohol consumption, autoimmune hepatitis, Wilson disease and alpha-1 anti-trypsin deficiency as the commonest causes3. It is projected that lifestyle modifications including eating habits and increase in the frequency of hepatitis B and C infections would increase the incidence of the disease by threefold in the next decade4.

The treatment options for the disease are diverse depending on the tumor size, location, time of diagnosis and associated co-morbidities. Small tumor with local restriction are offered surgical options including resection and/or tr

Group Type: EXPERIMENTAL

TACE

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of HCC disease
• Must be able to swallow tablets

Exclusion Criteria

• Insulin dependent diabetes
• Thyroid disease

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pak Emirates Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

DR.Talha Arshad

Professor Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

PakEmiratesMH

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Facility Contacts

Dr Rabbia Fatima Professor head of Radiology department,AFIRI,PEMH, Rawalpind, MBBS,FCPS,FRCR

Role: primary

rabbiafatimasattar555@gmail.com

03117055191

Other Identifiers

PakEmirates AFIRI

Identifier Type: -

Identifier Source: org_study_id