A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping (AA+IVC)

August 5, 2015 updated by: Chengjun Sui,MD, Eastern Hepatobiliary Surgery Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: anterior approach+IVC clamping
Use anterior approach combined with infrahepatic Inferior Vena Cava clamping in right hepatectomy for HCC patients.
Procedure: IVC clamping
in right hepatectomy,use anterior approach and infrahepatic Inferior Vena Cava clamping.
NO_INTERVENTION: anterior approach
Only use anterior approach in right hepatectomy for HCC patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intraoperative total blood loss
Time Frame: participants will be followed for the duration of the entire operation,an expected average of 140 minutes
participants will be followed for the duration of the entire operation,an expected average of 140 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
operation time
Time Frame: the duration of the entire operation,an expected average of 140 minutes
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
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
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 day 1,3 and 7
postoperative hospital stay
Time Frame: the duration of the postoperative hospital stay,an expected average of 15 days
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
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
the duration of the parenchymal transection,an expected average of 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Collaborators

The First Affiliated Hospital of Xiamen University

Investigators

  • Study Director: Jiamei Yang, MD, Eastern Hepatobiliary Surgery Hospital
  • Principal Investigator: Chengjun Sui, MD, Eastern Hepatobiliary Surgery Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 26, 2012

First Posted (ESTIMATE)

May 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBHKY2012-002-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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