Radiofrequency-assisted Liver Resection in Intractable Liver Cancer

Liver Cancer Clinical Trial

Official title:

The Application of Radiofrequency-assisted Liver Resection in Intractable Liver Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413526
• Other study ID #: radiofrequency liver resection
• Status: Completed
• Start date: May 25, 2020
• Est. completion date: November 18, 2021

Study information

• Verified date: November 2021
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this retrospective study, the investigators assessed the application of radiofrequency-assisted liver resection in intractable liver cancer resection, and plan to analysis the different factors.

Description:

The primary clinical treatment of liver cancer is surgical resection, although many integrated applications develop rapidly, surgery is still the best way to remove the tumour lesion. Traditional ways that have curative removed tumours in three methods, which are liver resection, liver transplantation and radiofrequency ablation (RFA).

As for primary liver cancer, surgery, and RFA are both effective and safety, but for the complexity of end-stage liver cancer, surgical resection may not remove the tumours alone. Surgical resection with radiofrequency ablation therapy for intractable liver cancer is a kind of active plan. The therapy can eliminate the tumour, maximize the protection of patient liver tissue, reduce operation damage, reduce the incidence of complications, and improve patients quality of life after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Ultrasound-guided fine-needle aspiration pathology or postoperative pathology was confirmed to be liver cancer, no pathological results according to China 's 2017 version of the hepatocarcinoma (HCC) diagnosis and treatment specifications, in line with the standard clinical diagnosis of liver cancer

• According to Barcelona Clinic Liver Cancer (BCLC) staging criteria, it is stage C (stage C: single tumour> 5 cm or more than three tumours, and at least one tumour> 3 cm, liver function Child-Pugh A or B, with lymph node metastasis or distant metastasis or portal vein or Venous liver trunk is invaded, penance Status (PST) score 1-2 points)

Exclusion Criteria:

• HCC patients with other malignant tumours

• Metastatic liver tumour

• Patients with liver abscess

• Patients with organ dysfunction

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Procedure:
• radiofrequency
radiofrequency combined with liver resection
• TACE
only TACE treatment
• TACE+radiofrequency
TACE followed by radiofrequency

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (1)

Sun Y, Ji S, Ji H, Liu L, Li C. Clinical efficacy analysis of transcatheter arterial chemoembolization (TACE) combined with radiofrequency ablation (RFA) in primary liver cancer and recurrent liver cancer. J BUON. 2019 Jul-Aug;24(4):1402-1407. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The survival rates for one-year to five-year	The survival rates was defined as the percentage of liver cancer for five years.	5 years
Secondary	The hospital stay	The length of stay in a hospital regarding days	3 months
Secondary	The Child-Pugh score after therapy	The Child-Pugh is based on the presence and severity of ascites and hepatic encephalopathy, the prolongation of prothrombin time, and the levels of serum bilirubin and albumin. According to the Child-Pugh scores, patients are classified into three classes (Child class A, B, and C with CP scores 5-6, 7-9, and 10-15, respectively)	3 months