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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
The First Affiliated Hospital of Xiamen University
Information provided by (Responsible Party):
Chengjun Sui,MD, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT01608386
First received: May 22, 2012
Last updated: August 5, 2015
Last verified: August 2015
  Purpose

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.


Condition Intervention
Surgical Approach & Incisions
Blood Loss
Procedure: IVC clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping Right Hepatic Resection for Large Hepatocellular Carcinoma: A Prospective Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • intraoperative total blood loss [ Time Frame: participants will be followed for the duration of the entire operation,an expected average of 140 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • operation time [ Time Frame: the duration of the entire operation,an expected average of 140 minutes ] [ Designated as safety issue: Yes ]
  • intraoperative CVP value [ Time Frame: participants will be followed for the duration of the parenchymal transection,an expected average of 20 minutes ] [ Designated as safety issue: Yes ]
  • morbidity and mortality [ Time Frame: participants will be followed for the duration of the postoperative hospital stay,an expected average of 15 days ] [ Designated as safety issue: Yes ]
  • postoperative hepatorenal function [ Time Frame: postoperative day 1,3 and 7 ] [ Designated as safety issue: Yes ]
  • postoperative hospital stay [ Time Frame: the duration of the postoperative hospital stay,an expected average of 15 days ] [ Designated as safety issue: Yes ]
  • disease-free survival duration and overall survival duration [ Time Frame: the duration from operation to recurrence or death,an expected average of 3 years ] [ Designated as safety issue: Yes ]
  • blood loss during parenchymal transection [ Time Frame: the duration of the parenchymal transection,an expected average of 20 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608386

Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
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
  More Information

No publications provided

Responsible Party: Chengjun Sui,MD, Clinical Professor, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT01608386     History of Changes
Other Study ID Numbers: EHBHKY2012-002-16
Study First Received: May 22, 2012
Last Updated: August 5, 2015
Health Authority: China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
Anterior approach
infrahepatic inferior vena cava clamping
hepatic resection

ClinicalTrials.gov processed this record on August 27, 2015