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Balloon assisted chemoembolization (BACE) for hepatocellular carcinoma: evaluation of safety and efficary

Balloon assisted chemoembolization (BACE) for hepatocellular carcinoma: evaluation of safety and efficary - Balloon assisted chemoembolization (BACE)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019172
Enrollment
52
Registered
2015-10-01
Start date
2015-10-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

hepatocellular carcinoma

Interventions

In cases where a large volume of normal hepatic parenchyma is expected to be damaged by ordinary chemoembolization, a microballoon catheter is used to temporarily occlude the artery perfusing the norm

Sponsors

University of Tsukuba Hospital
Lead Sponsor
Ibaraki prefectural central hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Diagnosis of hepatocellular carcinoma according to EASL guideline 2)Chemoembolization is indicated. 3)Performance status of 0-2 4)Liver function of Child-pugh A or B 5)eGFR is 30mL/min/1.73m2 or more 6)Platelet count of 50,000 microL or more 7)No previous treatment or 4 weeks after the previous treatment 8)Informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1)Rupture of hepatocellular carcinoma 2)History of surgical or endoscopic treatment of bile duct 3)Prominent arterioportal or arteriovenous shunts 4)Dissection or stenosis of 50% or more in the celiac trunk or hepatic artery 5)Hepatic coma or severe psychiatric disorder 6)Severe drug allergy including iodine contast allergy 7)Inadequate patients to undergo the procedure safely

Design outcomes

Primary

MeasureTime frame
To evaluate the safety of BACE, adverse events except for the side effects of chemoembolization are assessed according to SIR(Society of interventional radiology) standards of practice committee classification of complications by outcome.

Secondary

MeasureTime frame
The efficacy of BACE is assessed on contrast enhanced CT or MRI after 3 month according to RECICL classification.

Countries

Japan

Contacts

Public ContactKensaku Mori

Faculty of Medicine, University of Tsukuba Department of Radiology

moriken@md.tsukuba.ac.jp0298533205

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026