- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01768741
Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma
November 16, 2015 updated by: Xiujun Cai, Sir Run Run Shaw Hospital
A Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiujun Cai, MD
- Phone Number: 0086-0571-86006605
- Email: caixiujunzju@yahoo.com.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
-
Contact:
- Xiujun Cai, MD
- Phone Number: 0086-0571-86006605
- Email: caixiujunzju@yahoo.com.cn
-
Contact:
- Renan Jin, MS
- Phone Number: 0086-0571-86006276
- Email: jason198508@126.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Laparoscopic liver resection group
|
participants will be performed with laparoscopic hepatectomy using laparoscopic instruments
Other Names:
|
Active Comparator: Open liver resection
|
participants will be performed with open hepatectomy using laparotomic instruments
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total survival time and disease free survival time
Time Frame: up to 5 years
|
up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical margins
Time Frame: 7 days
|
7 days
|
|
Time to functional recovery
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
|
participants will be followed for the duration of hospital stay, an expected average of 6 days
|
|
Postoperative hospital stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 7 days
|
participants will be followed for the duration of hospital stay, an expected average of 7 days
|
|
Morbidity and mortality
Time Frame: up to 3 months
|
up to 3 months
|
|
Quality of life
Time Frame: up to 1 year
|
up to 1 year
|
|
Intraoperative parameters including operation time,pneumoperitoneum time, liver resection time, estimated blood loss,transfusion, as well as number,size and location of the tumor
Time Frame: participants will be followed for the duration of operation, an expected average of 90 min
|
participants will be followed for the duration of operation, an expected average of 90 min
|
|
Regulatory T cells and associated cytokines in peripheral blood
Time Frame: up to 5 years
|
Regulatory T cells and associated cytokines in peripheral blood will be tested 1day before operation,5 days, 3,6 months and 1,3,5 years after operation
|
up to 5 years
|
Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue
Time Frame: 7 days
|
7 days
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospital costs
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 9 days
|
participants will be followed for the duration of hospital stay, an expected average of 9 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: XiuJun Cai, MD, Sir Run Run Shaw Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
January 13, 2013
First Submitted That Met QC Criteria
January 13, 2013
First Posted (Estimate)
January 15, 2013
Study Record Updates
Last Update Posted (Estimate)
November 18, 2015
Last Update Submitted That Met QC Criteria
November 16, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRRSH20121225-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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