Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection

Not Applicable

• Conditions: Laparoscopic Hepatectomy; Hepatocellular Carcinoma
• Interventions: Procedure: laparoscopic hepatectomy; Procedure: open liver resection

• Registration Number: NCT02131441
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

Recent clinical experience showed that laparoscopic hepatectomy has advantages of minimally invasive compared to open liver resection, however, laparoscopic liver resection is still difficult and risky. Currently it is only carried out in a few large medical centers with slow development. The related research studies were retrospective analysis, there were no prospective randomized controlled multi-center study reported. Because of its relatively simple anatomical advantages, left liver seems to be as the best platform to ensure maximum safety and feasibility of prospective randomized study for laparoscopic hepatectomy .This project intends to carry out a prospective randomized controlled multi-center study to look for evidence of safety, efficacy and minimally invasive of laparoscopic left liver resection, evaluate the long-term efficacy including overall survival, disease-free survival as well as time to disease recurrence for the left liver carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-04-29
• Status Verified: 2014-05
• Study First Submitted QC: 2014-05-02
• Last Update Submitted: 2014-05-02
• Study First Posted: 2014-05-06
• Last Update Posted: 2014-05-06
• Primary Completion: 2018-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Child-pugh A-B
• Primary hepatocellular carcinoma of the left liver lobe
• Tumor size ≤5cm in diameter
• KPS≥60

Exclusion Criteria

• Significant abnormal liver function
• Significant abnormal Heart function
• Significant abnormal lung function
• Significant abnormal kidney function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic hepatectomy	laparoscopic hepatectomy	laparoscopic hepatectomy
open liver resection	open liver resection	open liver resection

Primary Outcome Measures

Name	Time	Method
time of operation	Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
status of the resection margins	Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
bile leakage	Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
abdominal adhesion	Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.
amount of bleeding	Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

Secondary Outcome Measures

Name	Time	Method
overall survival	Participants will be followed for 5 years.
disease-free survival	Participants will be followed for 5 years.
time to disease recurrence	Participants will be followed for 5 years.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital,Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China