Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

NCT ID: NCT01768741

Last Updated: 2015-11-18

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2021-12-31

Brief Summary

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The purpose of this study is to investigate the clinical value of laparoscopic liver resection in the treatment of hepatocellular carcinoma by assessing its Surgical and oncologic outcomes comparing with open liver resection.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laparoscopic liver resection group

Group Type ACTIVE_COMPARATOR

Laparoscopic liver resection

Intervention Type PROCEDURE

participants will be performed with laparoscopic hepatectomy using laparoscopic instruments

Open liver resection

Group Type ACTIVE_COMPARATOR

Open liver resection

Intervention Type PROCEDURE

participants will be performed with open hepatectomy using laparotomic instruments

Interventions

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Laparoscopic liver resection

participants will be performed with laparoscopic hepatectomy using laparoscopic instruments

Intervention Type PROCEDURE

Open liver resection

participants will be performed with open hepatectomy using laparotomic instruments

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic hepatectomy Open hepatectomy

Eligibility Criteria

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Inclusion Criteria

* Liver solid tumor, with clinical diagnosis of hepatocellular carcinoma
* Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ
* The tumor location and size do not affect the dissection of hepatic hilar region
* Tumor size less than 10cm
* Without portal vein tumor thrombus
* Without intrahepatic or distant metastasis
* Willingness to participate in the study
* Able to understand the nature of the study and what will be required of them
* Body mass index of between 18 and 35
* Child-Pugh classification of A to B
* American Society of Anesthesiologists (ASA) grading of I to III

Exclusion Criteria

* Pregnant or lactating women
* Unwillingness to participate
* Inability to give written informed consent
* Child-Pugh classification of C
* ASA grading of IV to V
* Tumor invasion of the inferior vena cava or confluence part of hepatic vein
* Decompensated liver cirrhosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiujun Cai

Executive Vice-President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiujun Cai, MD

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

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Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiujun Cai, MD

Role: CONTACT

0086-0571-86006605

Facility Contacts

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Xiujun Cai, MD

Role: primary

0086-0571-86006605

Renan Jin, MS

Role: backup

0086-0571-86006276

Other Identifiers

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SRRSH20121225-2

Identifier Type: -

Identifier Source: org_study_id