Cirrhosis, Hepatocellular Carcinoma
Conditions
Keywords
radiofrequency-assisted（RF）, hepatectomy, postoperative liver injury
Brief summary
Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the prognosis of HCC patients，especially for those with cirrhosis，is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.
Interventions
PROCEDURERadiofrequency-assisted Hepatectomy
Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.
PROCEDUREConventional Hepatectomy
Hepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical.
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged from 18 to 65 years , no gender restriction. * Clinical diagnosis of resectable HCC. * Preoperative liver function test showed Child-Pugh Class A or B. * Indocyanine green retention at 15 minutes (ICG-15) of \<30%. * Acceptable clotting profile :platelet count \> 50 x 109/L and a prolonged prothrombin time of \< 5 seconds. * Enough relative residual liver volume (%RLV) ≥ 40%. * No tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava. * No other anti-tumor therapy received before the treatment. * No metastasis in lymphnode or other organs. * Written consent inform assigned.
Exclusion criteria
* Pregnancy. * Intraoperative findings of tumor rupture，extrahepatic tumor or lymphnode metastasis. * Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative liver injury | postoperative 90 days | The degree of postoperative hepatic injury is assessed by daily measurements of postoperative aminotransferase (AST) and alanine aminotransferase (ALT) levels, serum bilirubin levels, and prothrombin times. Each patient is followed up within postoperative 90 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | postoperative 90 days | It is evaluated according to the the Clavien-Dindo Classification of surgical complications. Postoperative mortality and morbidity are measured. |
| Overall survival | 1,3,5-year overall survival | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood parameter change after operation | discharge from hospital (2 weeks) | Blood parameter change after operation is measured by postoperative blood routine test till the hospitalization. The estimated average postoperative hospitalization ranges from 10 ot 15 days (generally 2 weeks). If the incidence of postoperative hepatic insufficiency occurred beyond hospitalization,blood routine test is also necessarily counted in. |
Countries
China
Contacts
Primary ContactRui Guo, Master of Medicine
Backup ContactLi Liu, MD
Outcome results
None listed