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The research of transcatheter hepatic artery embolization in the treatment of symptomatic hepatic focal nodular hyperplasia: a multi-center clinical study

The research of transcatheter hepatic artery embolization in the treatment of symptomatic hepatic focal nodular hyperplasia: a multi-center clinical study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048590
Enrollment
Unknown
Registered
2021-07-11
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

hepatic focal nodular hyperplasia

Interventions

Control group :TAE with iodinated oil emulsion
interventional group:TAE with bleomycin hydrochloride-iodized oil emulsion

Sponsors

The First Medical Center of the General Hospital of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 50 years; 2. Pathological diagnosis of FNH; 3. Complete clinical, laboratory and imaging data; 4. Accompanied by abdominal pain, abdominal distension, low back pain and other symptoms, the medical treatment is invalid, which obviously affects the quality of life; 5. ECOG-PS score 0-1 points; 6. There are no other contraindications for angiography (such as contrast agent allergy, uncontrolled infection, uncorrectable coagulation disorder, etc.); 7. The subjects voluntarily joined the study, signed the informed consent, and were able to cooperate with the follow-up and complete the research project.

Exclusion criteria

Exclusion criteria: 1. Severe abnormal liver function (ALT/AST>=4ULN, DBIL>=3ULN) 2. Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN+4 seconds), with bleeding tendency or receiving thrombolytic or anticoagulation therapy; 3. Patients with grade II and above myelosuppression; 4. Active period of infectious disease; 5. Those with severe heart, lung, kidney, brain and other underlying diseases who cannot tolerate interventional therapy; 6. Those who cannot tolerate a complete treatment cycle (>=2 times) and cannot objectively evaluate the efficacy; 7. Menstrual period women wait until the end of the menstrual period.

Design outcomes

Primary

MeasureTime frame
disease control rate;

Countries

China

Contacts

Public ContactWang Maoqiang

The First Medical Center of the General Hospital of the Chinese People's Liberation Army

wangmq@vip.sina.com+86 10 66937190

Outcome results

None listed

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