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The clinical research of subhepatic radiofrequency ablation for primary hepatocellular carcinoma

The clinical research of subhepatic radiofrequency ablation for primary hepatocellular carcinoma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092783
Enrollment
Unknown
Registered
2024-11-22
Start date
2023-07-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Hepatocellular carcinoma

Interventions

Experimental group:Through preoperative CT hepatic vascular 3D imaging and color Doppler ultrasound, the subsegmental hepatic pedicle of the tumor-bearing liver was highly selectively searched and loc
Control group:Ultrasound-guided electrode needle was directly punctured into the tumor for radiofrequency ablation in a conventional way.

Sponsors

Southwest Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.The research object understands the research content and significance, and obtains written informed consent; 2.Gender is not limited, age = 18 years old, = 75 years old; 3.Patients had a history of HCC resection or RFA, and the clinical or pathological diagnosis of HCC was obtained according to the American ASSLD standard. The number of lesions was 1; the maximum lesion = 3cm, with enhanced CT or enhanced MRI as the standard; 4.Patients who could not or did not want to undergo resection again; 5.Child Pugh A (= 7 points), no need for treatment of pleural effusion and ascites and hepatic encephalopathy; the Eastern Cooperative Oncology Group (ECOG) behavioral status score was 0-1; 6.Within 7 days before enrollment, there were enough liver and kidney function, appropriate laboratory indicators ( untreated ) : hemoglobin ( HGB ) = 9.0g / dl, neutrophils = 1,500 / mm3, PLT = 50 × 109 / L, serum ALB = 28g / L, TBIL < 50umol / L, ALT, AST < 5 times the upper limit of normal value, Bun, Cr < 1.5 times the upper limit of normal value, INR < 1.7 or PT extension < 4s; 7.The tumor was located in the liver parenchyma, and there was a needle path through the liver parenchyma. There were no large blood vessels, bile ducts and important organs around the tumor; 8.No other anti-tumor treatment was received before operation.

Exclusion criteria

Exclusion criteria: 1.Serious heart and lung disease ; bleeding, coagulation dysfunction; portal hypertension; pregnancy; 2.ASA score: > 3; 3.Epilepsy, psychiatric patients; 4.Preoperative imaging showed that the lesion was close to the surface of the liver, gallbladder, important blood vessels in the hepatic portal, bile duct and surrounding important organs. It is expected that the operation may cause serious accidental injury and serious complications; 5.Clear extrahepatic metastasis and hepatic vascular tumor thrombus.

Design outcomes

Primary

MeasureTime frame
2-year overall survival ;2-year recurrence-free survival;

Secondary

MeasureTime frame
postoperative complication;Postoperative liver function;

Countries

China

Contacts

Public ContactHuaqiang Bi

Institution of Hepatobiliary Surgery, Southwest Hospital, Army Medical University

psycho_med@sina.com+86 139 9614 1977

Outcome results

None listed

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