Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma

Not Applicable

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Open hepatectomy; Procedure: laparoscopic hepatectomy

• Registration Number: NCT02526043
• Lead Sponsor: Fudan University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-05
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open hepatectomy	Open hepatectomy	The HCC patients who meet the Louisville consensus will be underwent the liver resection by open surgery
laparoscopic hepatectomy	laparoscopic hepatectomy	The HCC patients who meet the Louisville consensus will be underwent the liver resection by laparoscopic surgery

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	The overall survival of HCC patients after operation

Secondary Outcome Measures

Name	Time	Method
Disease free survival	5 years	The disease free survival of HCC patients after operation
Incidence of postoperative complications	1 month	Incidence of postoperative complications

Trial Locations

Locations (1)

Huashan hospital; 🇨🇳 Shanghai, China