NCT02131441

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

May 6, 2014

Status Verified

May 1, 2014

Enrollment Period

5.1 years

First QC Date

April 29, 2014

Last Update Submit

May 2, 2014

Conditions

Laparoscopic HepatectomyHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (5)

  • amount of bleeding

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

  • 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.

Secondary Outcomes (3)

  • 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.

Study Arms (2)

laparoscopic hepatectomy

OTHER

laparoscopic hepatectomy

Procedure: laparoscopic hepatectomy

open liver resection

OTHER

open liver resection

Procedure: open liver resection

Interventions

laparoscopic hepatectomyPROCEDURE
laparoscopic hepatectomy
open liver resectionPROCEDURE
open liver resection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Ya-Jin Chen, M.D.

CONTACT

00862034071169drcaojun@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the division of hepatobiliary surgery

Study Record Dates

First Submitted

April 29, 2014

First Posted

May 6, 2014

Study Start

July 1, 2013

Primary Completion

August 1, 2018

Study Completion

August 1, 2023

Last Updated

May 6, 2014

Record last verified: 2014-05

Locations

CN(1)