Hepatocellular CarcinomaPhase 2/3SHVENCT00820339
Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy
A Phase 2/3 study testing Selective Hepatic Vascular Exclusion and Pringle's Maneuver in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
To confirm that SHVE is a safe and effective procedure and it can prevent bleeding of the hepatic vein. To evaluate the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE.To evaluate that SHVE can improve survival in HCC patients or not. 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?
- Selective Hepatic Vascular Exclusion and Pringle's Maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Nov 2012
- Phase
- Phase 2/3
- 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
- Corresponding to diagnostic standards of HCC.
- Patients of liver tumors underwent resection with occlusion of more than one main hepatic veins.
- liver function in the Child-Pugh classification A or B.
- Age between 18~70 years.
- Haven't taken any current treatment.
- Understanding and being willing to sigh the informed consent form.
Who cannot join
- cannot be follow-up
- severe liver, renal, or brain dysfunction
- with tumor thrombi in the main trunk of portal vein
- with tumor thrombi in the hepatic vein
- with extrahepatic metastasis
Trial locations and contacts
1 site in 1 country.
China1 site
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality
About this study
Official title: Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy About Recurrence and Survival :A Prospective Randomized Trial
To confirm that SHVE is a safe and effective procedure and it can prevent bleeding of the hepatic vein. To evaluate the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE.To evaluate that SHVE can improve survival in HCC patients or not.
Read the detailed description
Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad still shows a rising trend. In recent decade, the overall survival rate of the disease has entered a platform stage with little advance despite diversified methods of treatment. The prognosis of HCC is not so satisfying.
Intraoperative bleeding remains a major concern during liver resection. Blood loss usually occurs during parenchymal transection and reperfusion after Pringle's maneuver. The amount of blood loss and the need for blood transfusion have a detrimental effect on the short- and long-term prognosis.
Portal triad clamping is sufficient in most situations to control bleeding during hepatectomy. However, it does not prevent backflow bleeding from hepatic veins, which may become troublesome or even hazardous. This is particularly true in tumors that are large or that have invaded into the branches of the major hepatic veins.
SHVE completely isolates the liver from the systemic circulation with the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.
The purpose of the study is to assess the risk factors for the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE and to evaluate that SHVE can improve survival in HCC patients or not.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Selective Hepatic Vascular Exclusion, Pringle's Maneuver
- Keywords
- hepatocellular carcinoma, hepatic vein, Surgical resection, occlusion, time to recurrence, overall survival
- Medical subject headings
- Carcinoma, Hepatocellular, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Hepatic Vascular ExclusionProcedure or surgery
Also called SHVE group
Inflow occlusion with extraparenchymal control of major hepatic veins results in total liver isolation from the systemic circulation but without interruption of caval flow.
Pringle's ManeuverProcedure or surgery
Also called Pringle's Maneuver group
Hepatic pedical clamping is performed by encircling the hepatoduodenal ligament with a tape and then applying a tourniquet or a vascular clamp until the pulse in the hepatic artery disappears distally.
| Study group | Role | What they receive |
|---|---|---|
| Selective Hepatic Vascular Exclusion | Active comparator | Patients with HCC received Selective Hepatic Vascular Exclusion in hepatectomy. Receives: Procedure: Selective Hepatic Vascular Exclusion |
| Pringle's Maneuver | Experimental | Patients with HCC received Pringle's Maneuver in hepatectomy. Receives: Procedure: Pringle's Maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 1,2,or 3 years
Secondary outcomes (1)
Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications
Measured: 1,2,or 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionNov 2012
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Feng Shen, M.D., Study chair, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820339
- Sponsor's protocol ID
- EHBH-RCT-2008-002
- Acronym
- SHVE
- Status last verified
- Mar 2016
- First submitted
- 9 Jan 2009
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy About Recurrence and Survival :A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00820339
- Acronym / sponsor ID
- SHVE / EHBH-RCT-2008-002
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, hepatic vein, Surgical resection, occlusion, time to recurrence, overall survival
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Jan 2009 (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.
To confirm that SHVE is a safe and effective procedure and it can prevent bleeding of the hepatic vein. To evaluate the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE.To evaluate that SHVE can improve survival in HCC patients or not.
Detailed description
Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad still shows a rising trend. In recent decade, the overall survival rate of the disease has entered a platform stage with little advance despite diversified methods of treatment. The prognosis of HCC is not so satisfying.
Intraoperative bleeding remains a major concern during liver resection. Blood loss usually occurs during parenchymal transection and reperfusion after Pringle's maneuver. The amount of blood loss and the need for blood transfusion have a detrimental effect on the short- and long-term prognosis.
Portal triad clamping is sufficient in most situations to control bleeding during hepatectomy. However, it does not prevent backflow bleeding from hepatic veins, which may become troublesome or even hazardous. This is particularly true in tumors that are large or that have invaded into the branches of the major hepatic veins.
SHVE completely isolates the liver from the systemic circulation with the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.
The purpose of the study is to assess the risk factors for the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE and to evaluate that SHVE can improve survival in HCC patients or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective Hepatic Vascular Exclusion | Active comparator | Procedure: Selective Hepatic Vascular ExclusionPatients with HCC received Selective Hepatic Vascular Exclusion in hepatectomy. |
| Pringle's Maneuver | Experimental | Procedure: Pringle's ManeuverPatients with HCC received Pringle's Maneuver in hepatectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Corresponding to diagnostic standards of HCC.
- Patients of liver tumors underwent resection with occlusion of more than one main hepatic veins.
- liver function in the Child-Pugh classification A or B.
- Age between 18~70 years.
- Haven't taken any current treatment.
Key exclusion criteria (5 listed)
- cannot be follow-up
- severe liver, renal, or brain dysfunction
- with tumor thrombi in the main trunk of portal vein
- with tumor thrombi in the hepatic vein
- with extrahepatic metastasis
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 |
|---|---|---|
| Selective Hepatic Vascular ExclusionAlso: SHVE groupInflow occlusion with extraparenchymal control of major hepatic veins results in total liver isolation from the systemic circulation but without interruption of caval flow. | Procedure or surgery | Selective Hepatic Vascular Exclusion |
| Pringle's ManeuverAlso: Pringle's Maneuver groupHepatic pedical clamping is performed by encircling the hepatoduodenal ligament with a tape and then applying a tourniquet or a vascular clamp until the pulse in the hepatic artery disappears distally. | Procedure or surgery | Pringle's Maneuver |
Primary outcome
Overall survival
Time frame: 1,2,or 3 years
1 secondary outcome
Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications
Time frame: 1,2,or 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
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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.
Feng Shen, M.D. study chair
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Selective Hepatic Vascular Exclusion and Pringle's Maneuver in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 1 Apr 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1,2,or 3 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 1 Apr 2016.