A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping (AA+IVC)
Primary Purpose
Surgical Approach & Incisions, Blood Loss
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IVC clamping
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Approach & Incisions focused on measuring Anterior approach, infrahepatic inferior vena cava clamping, hepatic resection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
anterior approach+IVC clamping
anterior approach
Arm Description
Use anterior approach combined with infrahepatic Inferior Vena Cava clamping in right hepatectomy for HCC patients.
Only use anterior approach in right hepatectomy for HCC patients.
Outcomes
Primary Outcome Measures
intraoperative total blood loss
Secondary Outcome Measures
operation time
intraoperative CVP value
morbidity and mortality
postoperative hepatorenal function
postoperative hospital stay
disease-free survival duration and overall survival duration
blood loss during parenchymal transection
Full Information
NCT ID
NCT01608386
First Posted
May 22, 2012
Last Updated
August 5, 2015
Sponsor
Eastern Hepatobiliary Surgery Hospital
Collaborators
The First Affiliated Hospital of Xiamen University
1. Study Identification
Unique Protocol Identification Number
NCT01608386
Brief Title
A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping
Acronym
AA+IVC
Official Title
Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping Right Hepatic Resection for Large Hepatocellular Carcinoma: A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital
Collaborators
The First Affiliated Hospital of Xiamen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Approach & Incisions, Blood Loss
Keywords
Anterior approach, infrahepatic inferior vena cava clamping, hepatic resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anterior approach+IVC clamping
Arm Type
Experimental
Arm Description
Use anterior approach combined with infrahepatic Inferior Vena Cava clamping in right hepatectomy for HCC patients.
Arm Title
anterior approach
Arm Type
No Intervention
Arm Description
Only use anterior approach in right hepatectomy for HCC patients.
Intervention Type
Procedure
Intervention Name(s)
IVC clamping
Intervention Description
in right hepatectomy,use anterior approach and infrahepatic Inferior Vena Cava clamping.
Primary Outcome Measure Information:
Title
intraoperative total blood loss
Time Frame
participants will be followed for the duration of the entire operation,an expected average of 140 minutes
Secondary Outcome Measure Information:
Title
operation time
Time Frame
the duration of the entire operation,an expected average of 140 minutes
Title
intraoperative CVP value
Time Frame
participants will be followed for the duration of the parenchymal transection,an expected average of 20 minutes
Title
morbidity and mortality
Time Frame
participants will be followed for the duration of the postoperative hospital stay,an expected average of 15 days
Title
postoperative hepatorenal function
Time Frame
postoperative day 1,3 and 7
Title
postoperative hospital stay
Time Frame
the duration of the postoperative hospital stay,an expected average of 15 days
Title
disease-free survival duration and overall survival duration
Time Frame
the duration from operation to recurrence or death,an expected average of 3 years
Title
blood loss during parenchymal transection
Time Frame
the duration of the parenchymal transection,an expected average of 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiamei Yang, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chengjun Sui, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping
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