Clinical trial NCT03313648: A Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC
Official title: A RCT Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma Recurrent
Keywords: Recurrent HCC
Laparoscopic Hepatectomy
RFA
RCT
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two different treatments are conducted on the participant base on the randomized choices
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Survival rate
timeFrame: 5 years
Secondary outcomes:
measure: intraoperative parameters
timeFrame: during the operation
Other outcomes:
measure: postoperative complications
timeFrame: Duration hospitalization(an expected average of 7 days)
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
affiliation: Shuguo Zheng, MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
name: Shuguo Zheng
role: STUDY_DIRECTOR
References: