Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

Fudan University

Status: Active, not recruiting

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Open hepatectomy; Procedure: laparoscopic hepatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02526043

Huashan 002

Details and patient eligibility

About

The purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma.

Full description

Liver resection is the most important treatment of hepatocellular carcinoma (HCC). Open hepatectomy was regarded as a giant surgery because of its big incision, influence of the liver function, and long hospital stay. Laparoscopic hepatectomy was widely used since it was reported by Reich in 1991. With the constant innovation of laparoscopic technique and equipment, there is no penalty area in laparoscopic hepatectomy. The Louisville consensus proposed that the best indication for laparoscopic hepatectomy was the tumor diameter < 5cm, located in segment II-VI.

Previous studies shows that compared with the open surgery, laparoscopic hepatectomy has the advantages of shorter operation time, less bleeding, shorter hospitalization time. The mortality, mobility, the overall survival and the disease-free survival was same in these two groups.

So far, however, the curative effect and safety research of laparoscopic versus open liver resection for HCC is limited to retrospective study and case-control study. A prospective, randomized, controlled study is urgently needed.

This study was proceeded to observe the curative effect and safety of laparoscopic versus open liver resection for HCC.

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis was HCC
2. The tumor was located in segment: II, III, IVb, V, VI
3. The tumor diameter < 5cm
4. Without thrombosis in the portal vein, hepatic vein or bile duct
5. Without intrahepatic and systemic metastasis
6. The Child-pugh score was A-B7
7. The ASA（American Society of Anesthesiologists） score was I-III
8. The patient age was between 18-75
9. Sign the informed consent, and can fully understand the research content

Exclusion criteria

1. Have surgery contraindications
2. Pregnant or lactating women
3. The Child-pugh score was B8-C
4. The ASA（American Society of Anesthesiologists） score was IV-V
5. With other malignant tumor
6. With mental illness
7. Participated in other clinical trials in the last three months
8. Underwent other treatments(chemotherapy or radiotherapy) before operation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

laparoscopic hepatectomy

Experimental group

Description:

The HCC patients who meet the Louisville consensus will be underwent the liver resection by laparoscopic surgery

Treatment:

Procedure: laparoscopic hepatectomy

Open hepatectomy

Experimental group

Description:

The HCC patients who meet the Louisville consensus will be underwent the liver resection by open surgery

Treatment:

Procedure: Open hepatectomy