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Clinical Trials/NCT02131441
NCT02131441UnknownNot Applicable

Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 site in 1 country2 target enrollmentStarted: July 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
2
Locations
1
Primary Endpoint
time of operation

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

time of operation

Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

status of the resection margins

Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

bile leakage

Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

abdominal adhesion

Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

amount of bleeding

Time Frame: Participants will be observed for the duration of hospital stay, an expected average of 4 weeks.

Secondary Outcomes

  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ya-jin Chen

Chief of the division of hepatobiliary surgery

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Sites (1)

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