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

Army Medical University

Status: Unknown

Conditions: Hepatocellular Carcinoma Recurrent

Treatments: Procedure: Laparoscopic Hepatectomy; Procedure: Radiofrequency Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03313648

SWHZSG007

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Laparoscopic Hepatectomy

Experimental group

Description:

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.

Treatment:

Procedure: Laparoscopic Hepatectomy

Radiofrequency Ablation

Active Comparator group

Description:

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 .

Treatment:

Procedure: Radiofrequency Ablation