Clinical trial NCT02526043: Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma
Official title: A Prospective Randomized Control Trail of Laparoscopic Versus Open Liver Resection for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 5 years
measure: Incidence of postoperative complications
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan hospital
Study officials:
affiliation: Department of general surgery, Huashan hospital, Fudan University
name: Lunxiu Qin, MD
role: PRINCIPAL_INVESTIGATOR
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