Hepatocellular CarcinomaNCT01992978
Radiofrequency-assisted Hepatectomy on the Outcomes of HCC Patients With Cirrhosis
A study testing Radiofrequency-assisted Hepatectomy and Conventional Hepatectomy in people with Hepatocellular Carcinoma and Cirrhosis, run by Southwest Hospital, China at 1 site in China.
Trial summary
Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma, Cirrhosis
- What is being tested?
- Radiofrequency-assisted Hepatectomy and Conventional Hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 65 years , no gender restriction.
- Clinical diagnosis of resectable HCC.
- Preoperative liver function test showed Child-Pugh Class A or B.
- Indocyanine green retention at 15 minutes (ICG-15) of <30%.
- Acceptable clotting profile :platelet count > 50 x 109/L and a prolonged prothrombin time of < 5 seconds.
- Enough relative residual liver volume (%RLV) ≥ 40%.
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- No tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
- No other anti-tumor therapy received before the treatment.
- No metastasis in lymphnode or other organs.
- Written consent inform assigned.
Who cannot join
- Pregnancy.
- Intraoperative findings of tumor rupture，extrahepatic tumor or lymphnode metastasis.
- Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hepatobiliry surgery,Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Rui Guo, Master of Medicine, 86-23-15922654727, ruixx032@163.com
Xiaowu Li, MD-Ph D
About this study
Official title: The Influence of Radiofrequency-assisted Hepatectomy on the Perioperative Outcomes and the Long-term Prognosis of HCC With Cirrhosis：A Prospective Randomized Controlled Trial
Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the prognosis of HCC patients，especially for those with cirrhosis，is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.
- Conditions
- Hepatocellular Carcinoma, Cirrhosis
- Being tested
- Radiofrequency-assisted Hepatectomy, Conventional Hepatectomy
- Keywords
- radiofrequency-assisted（RF）, hepatectomy, postoperative liver injury
- Medical subject headings
- Carcinoma, Hepatocellular, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency-assisted HepatectomyProcedure or surgery
Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.
Conventional HepatectomyProcedure or surgery
Hepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical.
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency-assisted resection group（RF-R) | Experimental | Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection. Receives: Procedure: Radiofrequency-assisted Hepatectomy |
| conventional liver resection group（CLR-R） | Active comparator | Conventional liver resection group: hepatectomy only without RF assisted during parenchymal transection.Separating and dissecting the tumor with the routine clamp-crushing technical. Receives: Procedure: Conventional Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative liver injury
The degree of postoperative hepatic injury is assessed by daily measurements of postoperative aminotransferase (AST) and alanine aminotransferase (ALT) levels, serum bilirubin levels, and prothrombin times. Each patient is followed up within postoperative 90 days.
Measured: postoperative 90 days
Secondary outcomes (2)
Number of Participants with Adverse Events
It is evaluated according to the the Clavien-Dindo Classification of surgical complications. Postoperative mortality and morbidity are measured.
Measured: postoperative 90 days
Overall survival
Measured: 1,3,5-year overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2017 (estimated)
- Study completionDec 2018 (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.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwest Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Xiaowu,MD, Southwest Hospital, China
- Investigators
- Xiaowu Li, MD-Ph D, Study director, Institute of hepatobiliry surgery,Southwest hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992978
- Sponsor's protocol ID
- SWHB2013-005
- Status last verified
- Nov 2015
- First submitted
- 11 Nov 2013
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Radiofrequency-assisted Hepatectomy on the Perioperative Outcomes and the Long-term Prognosis of HCC With Cirrhosis：A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01992978
- Acronym / sponsor ID
- SWHB2013-005
- Conditions
- Hepatocellular Carcinoma, Cirrhosis
- Keywords
- radiofrequency-assisted（RF）, hepatectomy, postoperative liver injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Southwest Hospital, ChinaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Nov 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.
Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the prognosis of HCC patients，especially for those with cirrhosis，is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency-assisted resection group（RF-R) | Experimental | Procedure: Radiofrequency-assisted HepatectomyRadiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection. |
| conventional liver resection group（CLR-R） | Active comparator | Procedure: Conventional HepatectomyConventional liver resection group: hepatectomy only without RF assisted during parenchymal transection.Separating and dissecting the tumor with the routine clamp-crushing technical. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged from 18 to 65 years , no gender restriction.
- Clinical diagnosis of resectable HCC.
- Preoperative liver function test showed Child-Pugh Class A or B.
- Indocyanine green retention at 15 minutes (ICG-15) of <30%.
- Acceptable clotting profile :platelet count > 50 x 109/L and a prolonged prothrombin time of < 5 seconds.
Key exclusion criteria (3 listed)
- Pregnancy.
- Intraoperative findings of tumor rupture，extrahepatic tumor or lymphnode metastasis.
- Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
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 |
|---|---|---|
| Radiofrequency-assisted HepatectomyRadiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection. | Procedure or surgery | radiofrequency-assisted resection group（RF-R) |
| Conventional HepatectomyHepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical. | Procedure or surgery | conventional liver resection group（CLR-R） |
Primary outcome
Postoperative liver injury
Time frame: postoperative 90 days
The degree of postoperative hepatic injury is assessed by daily measurements of postoperative aminotransferase (AST) and alanine aminotransferase (ALT) levels, serum bilirubin levels, and prothrombin times. Each patient is followed up within postoperative 90 days.
2 secondary outcomes
Number of Participants with Adverse Events
Time frame: postoperative 90 days
Overall survival
Time frame: 1,3,5-year overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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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.
Xiaowu Li, MD-Ph D study director
Institute of hepatobiliry surgery,Southwest 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 Radiofrequency-assisted Hepatectomy and Conventional Hepatectomy in people with Hepatocellular Carcinoma and Cirrhosis, run by Southwest Hospital, China 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 10 inclusion and 3 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 24 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 Rui Guo, Master of Medicine (86-23-15922654727, ruixx032@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative liver injury (time frame: postoperative 90 days). 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 24 Nov 2015.