A Study of Laparoscopic Hepatectomy Versus RFA in the Treatment of Recurrent HCC

Not Applicable

• Conditions: Hepatocellular Carcinoma Recurrent
• Interventions: Procedure: Laparoscopic Hepatectomy; Procedure: Radiofrequency Ablation

• Registration Number: NCT03313648
• Lead Sponsor: Southwest Hospital, China

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.

Study Timeline

• Study Start: 2016-09-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-13
• Last Update Submitted: 2017-10-13
• Study First Posted: 2017-10-18
• Last Update Posted: 2017-10-18
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic Hepatectomy	Laparoscopic Hepatectomy	Improvements in laparoscopic technology mean that LH now has superior short-term efficacy and similar long-term efficacy to open surgery , and LH has shown significant advantages in applications involving recurrent HCC.
Radiofrequency Ablation	Radiofrequency Ablation	With recent technological advances, RFA has become the most widely investigated new first-line therapeutic option for recurrent HCCs . Numerous large studies have demonstrated the advantages of RFA, which include its ease of use, safety, effectiveness, minimal invasiveness, and minimal morbidity and mortality .

Primary Outcome Measures

Name	Time	Method
Survival rate	5 years	follow-up after the surgery every 3 months, to understand statistics 5-year survival.

Secondary Outcome Measures

Name	Time	Method
intraoperative parameters	during the operation	operation time and hepatic inflow occlusion time will be combined to report intraoperative parameters in hour(h).

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China