Surgical Specification and Efficacy Evaluation of Total Laparoscopic Left Liver Resection

NCT ID: NCT02131441

Last Updated: 2014-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2023-08-31

Brief Summary

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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

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Conditions

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Laparoscopic Hepatectomy Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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laparoscopic hepatectomy

laparoscopic hepatectomy

Group Type OTHER

laparoscopic hepatectomy

Intervention Type PROCEDURE

open liver resection

open liver resection

Group Type OTHER

open liver resection

Intervention Type PROCEDURE

Interventions

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laparoscopic hepatectomy

Intervention Type PROCEDURE

open liver resection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Ya-jin Chen

Chief of the division of hepatobiliary surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ya-Jin Chen, M.D.

Role: CONTACT

00862034071169

Facility Contacts

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Yan-qing Zhou

Role: primary

00862081332371

Other Identifiers

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2013005

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TLLLR-001

Identifier Type: -

Identifier Source: org_study_id

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