Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection

Hepatocellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02131441
• Other study ID #: TLLLR-001
• Secondary ID: 2013005
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2014
• Last updated: May 2, 2014
• Start date: July 2013
• Est. completion date: August 2023

Study information

• Verified date: May 2014
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Ya-Jin Chen, M.D.
• Phone: 00862034071169
• Email: drcaojun[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: August 2023
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Laparoscopic Hepatectomy

Intervention

Procedure:
• laparoscopic hepatectomy

• open liver resection

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital,Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of bleeding		Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.	Yes
Primary	time of operation		Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.	Yes
Primary	status of the resection margins		Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.	Yes
Primary	bile leakage		Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.	Yes
Primary	abdominal adhesion		Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.	Yes
Secondary	overall survival		Participants will be followed for 5 years.	Yes
Secondary	disease-free survival		Participants will be followed for 5 years.	Yes
Secondary	time to disease recurrence		Participants will be followed for 5 years.	Yes