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Increasing the local pH during chemoembolization for hepatocellular carcinoma

Increasing pH with bicarbonate to enhance transarterial chemoembolization for hepatocellular carcinoma.A randomized controlled trail.(TACE+Bicarb).

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/028095
Enrollment
10
Registered
2020-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C220- Liver cell carcinoma Health Condition 2: C00-D49- Neoplasms

Interventions

Intervention1: sodium bicarbonate: Before doing standard TACE, In each tumor feeding artery, about 25â??ml bicarbonate would be injected into tumor feeding artery. Maximum of 3 arteries will be treate

Sponsors

TATA MEDICAL CENTER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - All patients with hepatocellular carcinoma who are candidates for trans-arterial chemoembolization - Patients who consent for the study - A diagnosis of HCC based on EASL or histological evidence, - Barcelona Clinic Liver Cancer (BCLC) stage A, B , - Child-pugh A , - Hypervascular lesion as evaluated by triphasic MRI or CT and digital subtraction angiography (DSA).

Exclusion criteria

Exclusion criteria: - BCLC -C , D, - Child pugh B,C - Evidence of combined A-V shunt. - Main portal vein thrombus - General contraindication for TACE

Design outcomes

Primary

MeasureTime frame
- Safety of adding bicarbonate along with TACETimepoint: 1 MONTH, 3 MONTH, 6 MONTH

Secondary

MeasureTime frame
- Overall survival post TACE on an intention to treat analysis - Progression free survival post TACE - Remaining viable tumor post TACE at follow-up scan - Survival stratified by stage Timepoint: 3 YEARS

Countries

India

Contacts

Public ContactDAYANANDA LINGEGOWDA

TATA MEDICAL CENTER

dayananda.lingegowda@tmckolkata.com7044198445

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026