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

Hepatocellular Carcinoma Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03313648
• Other study ID #: SWHZSG007
• Status: Recruiting
• Phase: N/A
• First received: October 5, 2017
• Last updated: October 13, 2017
• Start date: September 1, 2016
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2017
• Source: Southwest Hospital, China
• Contact: Shuguo Zheng
• Phone: 0086-13508308676
• Email: shuguozh[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Recurrent

Intervention

Procedure:
• Laparoscopic 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.
• Radiofrequency 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.

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative complications	hepatic failure,hemorrhage,biliary leakage,ascites,intra-abdominal infection,pleural effusion,pulmonary infection,cardiac insufficiency.	Duration hospitalization(an expected average of 7 days)
Primary	Survival rate	follow-up after the surgery every 3 months, to understand statistics 5-year survival.	5 years
Secondary	intraoperative parameters	operation time and hepatic inflow occlusion time will be combined to report intraoperative parameters in hour(h).	during the operation