Surgical Approach & IncisionsAA+IVCNCT01608386
A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping
A study testing IVC clamping in people with Surgical Approach & Incisions and Blood Loss, run by Eastern Hepatobiliary Surgery Hospital.
Trial summary
Anterior approach results in better operative and survival outcomes compared with the conventional approach in patients with large hepatocellular carcinoma (HCC), but anterior approach has the problem of bleeding from the hepatic vein. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgical Approach & Incisions, Blood Loss
- What is being tested?
- IVC clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Dec 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understanding and being willing to sign the informed consent form
- Aged 18-75 years
- Diagnosed HCC by clinical findings and radiography，tumor size ≥ 5cm and located in the right lobe, need to perform right hemihepatectomy or major right hepatic resection (three Couinaud's segments)
- Without any surgery contraindication
- Child-Pugh grade A
Who cannot join
- Refusal to take part in the study
- With lymph node or extrahepatic metastases
- History of previous hepatectomy or other abdominal operation
- Those who can not be follow-up
- Non-HCC
About this study
Official title: Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping Right Hepatic Resection for Large Hepatocellular Carcinoma: A Prospective Randomized Controlled Study
Anterior approach results in better operative and survival outcomes compared with the conventional approach in patients with large hepatocellular carcinoma (HCC), but anterior approach has the problem of bleeding from the hepatic vein.
Our previous study showed that infrahepatic inferior vena cava (IVC) clamping can reduce blood loss during conventional hepatic resection. The investigators guess infrahepatic IVC clamping may also reduce blood loss in anterior approach right hepatic resection. So the investigators conduct this prospective, randomized, controlled trial to compare anterior approach combined with infrahepatic IVC clamping and anterior approach in major right hepatectomy for large HCC.
Read the detailed description
Traditionally, mobilisation of the right hemiliver followed by right hepatic vein control before parenchymal transection has been considered the standard approach to a major right hepatectomy. However, this approach is often difficult and hazardous when performing liver resection for large hepatocellular carcinoma (HCC) or for tumors with extrahepatic organ invasion in the right retrohepatic region.In setting of right hepatectomy by an anterior approach,liver mobilisation is performed only at the end of parenchymal transection, when all vascular connections have already been interrupted.The anterior approach was found to be associated with significantly less intraoperative blood loss, less blood transfusions and a lower hospital mortality rate.However,excessive bleeding can occur at the deeper plane of parenchymal transection from the right hepatic vein or middle hepatic vein.
Bleeding from the hepatic veins is closely related to the CVP.Our previous retrospective analysisfound that the infrahepatic inferior vena cava (IVC) clamping is efficacious in reducing CVP without the need of systemic fluid restriction and is associated with significantly less intraoperative blood loss during complex hepatectomy.
The aim of the present study was therefore to evaluate if the application of the anterior approach combined with infrahepatic IVC clamping during right hepatectomy for large HCC reduces intraoperative blood loss.
- Conditions
- Surgical Approach & Incisions, Blood Loss
- Being tested
- IVC clamping
- Keywords
- Anterior approach, infrahepatic inferior vena cava clamping, hepatic resection
- Medical subject headings
- Surgical Wound, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVC clampingProcedure or surgery
in right hepatectomy,use anterior approach and infrahepatic Inferior Vena Cava clamping.
| Study group | Role | What they receive |
|---|---|---|
| anterior approach+IVC clamping | Experimental | Use anterior approach combined with infrahepatic Inferior Vena Cava clamping in right hepatectomy for HCC patients. Receives: Procedure: IVC clamping |
| anterior approach | No intervention | Only use anterior approach in right hepatectomy for HCC patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative total blood loss
Measured: participants will be followed for the duration of the entire operation,an expected average of 140 minutes
Secondary outcomes (7)
operation time
Measured: the duration of the entire operation,an expected average of 140 minutes
intraoperative CVP value
Measured: participants will be followed for the duration of the parenchymal transection,an expected average of 20 minutes
morbidity and mortality
Measured: participants will be followed for the duration of the postoperative hospital stay,an expected average of 15 days
postoperative hepatorenal function
Measured: postoperative day 1,3 and 7
postoperative hospital stay
Measured: the duration of the postoperative hospital stay,an expected average of 15 days
disease-free survival duration and overall survival duration
Measured: the duration from operation to recurrence or death,an expected average of 3 years
blood loss during parenchymal transection
Measured: the duration of the parenchymal transection,an expected average of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Approach & IncisionsStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University
- Responsible party
- Principal investigator, Chengjun Sui,MD, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Jiamei Yang, MD, Study director, Eastern Hepatobiliary Surgery HospitalChengjun Sui, MD, Principal investigator, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608386
- Sponsor's protocol ID
- EHBHKY2012-002-16
- Acronym
- AA+IVC
- Status last verified
- Aug 2015
- First submitted
- 22 May 2012
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping Right Hepatic Resection for Large Hepatocellular Carcinoma: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01608386
- Acronym / sponsor ID
- AA+IVC / EHBHKY2012-002-16
- Conditions
- Surgical Approach & Incisions, Blood Loss
- Keywords
- Anterior approach, infrahepatic inferior vena cava clamping, hepatic resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University
- Study start
- May 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 May 2012 (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.
Anterior approach results in better operative and survival outcomes compared with the conventional approach in patients with large hepatocellular carcinoma (HCC), but anterior approach has the problem of bleeding from the hepatic vein.
Our previous study showed that infrahepatic inferior vena cava (IVC) clamping can reduce blood loss during conventional hepatic resection. The investigators guess infrahepatic IVC clamping may also reduce blood loss in anterior approach right hepatic resection. So the investigators conduct this prospective, randomized, controlled trial to compare anterior approach combined with infrahepatic IVC clamping and anterior approach in major right hepatectomy for large HCC.
Detailed description
Traditionally, mobilisation of the right hemiliver followed by right hepatic vein control before parenchymal transection has been considered the standard approach to a major right hepatectomy. However, this approach is often difficult and hazardous when performing liver resection for large hepatocellular carcinoma (HCC) or for tumors with extrahepatic organ invasion in the right retrohepatic region.In setting of right hepatectomy by an anterior approach,liver mobilisation is performed only at the end of parenchymal transection, when all vascular connections have already been interrupted.The anterior approach was found to be associated with significantly less intraoperative blood loss, less blood transfusions and a lower hospital mortality rate.However,excessive bleeding can occur at the deeper plane of parenchymal transection from the right hepatic vein or middle hepatic vein.
Bleeding from the hepatic veins is closely related to the CVP.Our previous retrospective analysisfound that the infrahepatic inferior vena cava (IVC) clamping is efficacious in reducing CVP without the need of systemic fluid restriction and is associated with significantly less intraoperative blood loss during complex hepatectomy.
The aim of the present study was therefore to evaluate if the application of the anterior approach combined with infrahepatic IVC clamping during right hepatectomy for large HCC reduces intraoperative blood loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anterior approach+IVC clamping | Experimental | Procedure: IVC clampingUse anterior approach combined with infrahepatic Inferior Vena Cava clamping in right hepatectomy for HCC patients. |
| anterior approach | No intervention | –Only use anterior approach in right hepatectomy for HCC patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Understanding and being willing to sign the informed consent form
- Aged 18-75 years
- Diagnosed HCC by clinical findings and radiography，tumor size ≥ 5cm and located in the right lobe, need to perform right hemihepatectomy or major right hepatic resection (three Couinaud's segments)
- Without any surgery contraindication
- Child-Pugh grade A
Key exclusion criteria (5 listed)
- Refusal to take part in the study
- With lymph node or extrahepatic metastases
- History of previous hepatectomy or other abdominal operation
- Those who can not be follow-up
- Non-HCC
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 |
|---|---|---|
| IVC clampingin right hepatectomy,use anterior approach and infrahepatic Inferior Vena Cava clamping. | Procedure or surgery | anterior approach+IVC clamping |
Primary outcome
intraoperative total blood loss
Time frame: participants will be followed for the duration of the entire operation,an expected average of 140 minutes
7 secondary outcomes
operation time
Time frame: the duration of the entire operation,an expected average of 140 minutes
intraoperative CVP value
Time frame: participants will be followed for the duration of the parenchymal transection,an expected average of 20 minutes
morbidity and mortality
Time frame: participants will be followed for the duration of the postoperative hospital stay,an expected average of 15 days
postoperative hepatorenal function
Time frame: postoperative day 1,3 and 7
postoperative hospital stay
Time frame: the duration of the postoperative hospital stay,an expected average of 15 days
disease-free survival duration and overall survival duration
Time frame: the duration from operation to recurrence or death,an expected average of 3 years
blood loss during parenchymal transection
Time frame: the duration of the parenchymal transection,an expected average of 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 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.
Jiamei Yang, MD study director
Eastern Hepatobiliary Surgery Hospital
Chengjun Sui, MD principal investigator
Eastern Hepatobiliary Surgery Hospital
Questions about this trial
What is this clinical trial studying?
A study testing IVC clamping in people with Surgical Approach & Incisions and Blood Loss, run by Eastern Hepatobiliary Surgery Hospital.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
intraoperative total blood loss (time frame: participants will be followed for the duration of the entire operation,an expected average of 140 minutes). 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 6 Aug 2015.