Hepatocellular CarcinomaNCT01768741
Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma
A study testing Laparoscopic liver resection and Open liver resection in people with Hepatocellular Carcinoma, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Laparoscopic liver resection and Open liver resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000
Xiujun Cai, MD, 0086-0571-86006605, caixiujunzju@yahoo.com.cn
Renan Jin, MS, 0086-0571-86006276, jason198508@126.com
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Laparoscopic liver resection, Open liver resection
- Keywords
- hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic liver resectionProcedure or surgery
Also called Laparoscopic hepatectomy
participants will be performed with laparoscopic hepatectomy using laparoscopic instruments
Open liver resectionProcedure or surgery
Also called Open hepatectomy
participants will be performed with open hepatectomy using laparotomic instruments
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic liver resection group | Active comparator | Not described Receives: Procedure: Laparoscopic liver resection |
| Open liver resection | Active comparator | Not described Receives: Procedure: Open liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total survival time and disease free survival time
Measured: up to 5 years
Secondary outcomes (8)
Surgical margins
Measured: 7 days
Time to functional recovery
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 days
Postoperative hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 7 days
Morbidity and mortality
Measured: up to 3 months
Quality of life
Measured: 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
Measured: participants will be followed for the duration of operation, an expected average of 90 min
Regulatory T cells and associated cytokines in peripheral blood
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
Measured: up to 5 years
Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiujun Cai, Sir Run Run Shaw Hospital
- Investigators
- Xiujun Cai, MD, Principal investigator, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768741
- Sponsor's protocol ID
- SRRSH20121225-2
- Status last verified
- Nov 2015
- First submitted
- 13 Jan 2013
- Last updated
- 18 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01768741
- Acronym / sponsor ID
- SRRSH20121225-2
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic liver resection group | Active comparator | Procedure: Laparoscopic liver resection |
| Open liver resection | Active comparator | Procedure: Open liver resection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Unwillingness to participate
- Inability to give written informed consent
- Child-Pugh classification of C
- ASA grading of IV to V
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic liver resectionAlso: Laparoscopic hepatectomyparticipants will be performed with laparoscopic hepatectomy using laparoscopic instruments | Procedure or surgery | Laparoscopic liver resection group |
| Open liver resectionAlso: Open hepatectomyparticipants will be performed with open hepatectomy using laparotomic instruments | Procedure or surgery | Open liver resection |
Primary outcome
Total survival time and disease free survival time
Time frame: up to 5 years
8 secondary outcomes
Surgical margins
Time frame: 7 days
Time to functional recovery
Time frame: 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
Morbidity and mortality
Time frame: up to 3 months
Quality of life
Time frame: 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
Regulatory T cells and associated cytokines in peripheral blood
Time frame: up to 5 years
Regulatory T cells and associated cytokines in liver cancer、para-carcinoma and healthy liver tissue
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiujun Cai, MD principal investigator
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic liver resection and Open liver resection in people with Hepatocellular Carcinoma, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiujun Cai, MD (0086-0571-86006605, caixiujunzju@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total survival time and disease free survival time (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.