Hepatocellular Carcinoma Recurrent
Conditions
Keywords
Recurrent HCC, Laparoscopic Hepatectomy, RFA, RCT
Brief summary
To observe and compare the short-term and long-term oncological outcome of laparoscopic hepatectomy and radiofrequency ablation in the treatment of recurrent hepatocellular carcinoma .
Detailed description
Background & Aims: Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death in the world. The 5-year recurrent rate of HCC after first curative resection is 77%\ 100%. Laparoscopic repeat liver resection (LRLR) has been shown in small retrospective studies to be a safe and effective treatment for recurrent hepatocellular carcinoma (rHCC) in selected patients, and radiofrequency ablation (RFA) has been increasingly performed for treating recurrent tumors involving the liver after hepatectomy. The aim of this study was to compare the short-term and long-term outcome of laparoscopic hepatectomy (LH) and radiofrequency ablation (RFA) in the treatment of rHCC.
Interventions
PROCEDURELaparoscopic Hepatectomy
180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.
PROCEDURERadiofrequency Ablation
180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.
Sponsors
Southwest Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Two different treatments are conducted on the participant base on the randomized choices
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Any gender,18 to 70 years old; * Preoperative diagnosis of recurrent HCC clear,liver resection was done previously; * No active hepatitis and decompensated cirrhosis; * Patient with previous liver resection, maximum diameter ≤5cm single recurrent nodules or 3 nodules in diameter and no more than 3cm,did not infringe the portal vein,hepatic vein and inferior vena cava invasion,lymph node or extrahepatic turn; * No tumor rupture or bleeding; * Child-Pugh class A or B grade,ICG-R15 \<20%; * No coagulation disorders,platelet count \> 50 × 109 / L and prolonged prothrombin time \< 5 seconds; * After diagnosis of recurrent HCC,not be including related surgery,radiofrequency ablation (RFA),TACE treatment,no certainty anticancer chemotherapy treatment;supreme absolute contraindications abdominal surgery; * Recurrent nodules are not close to intestines,stomach,cholecyst or diaphragm muscle, not close to the first porta hepatis,main vessel and biliary ducts; * Patients generally available,heart and lung function can tolerate surgery, abdominal surgery supreme absolute contraindications; * Voluntarily participate in the study, voluntarily accept any therapy of two,informed consent.
Exclusion criteria
* Opposite of the above inclusion criteria; * Severe upper abdominal adhesions; * Postoperative pathological examination of the bile duct cell or mixed cell carcinoma and pathologically confirmed positive margin; * Foreign,Hong Kong,Macao,Taiwan and other regions,estimated postoperative difficult to track,followed up; * Nodules proved to be not recurrent HCC during intraoperative exploration, such as:liver metastases of colorectal cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 5 years | follow-up after the surgery every 3 months, to understand statistics 5-year survival. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative parameters | during the operation | operation time and hepatic inflow occlusion time will be combined to report intraoperative parameters in hour(h). |
Other
| Measure | Time frame | Description |
|---|---|---|
| postoperative complications | Duration hospitalization(an expected average of 7 days) | hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency. |
Countries
China
Contacts
Primary ContactShuguo Zheng
Outcome results
None listed