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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Chengjun Sui,MD, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT01608386
First received: May 22, 2012
Last updated: May 26, 2012
Last verified: May 2012
History of Changes
  Purpose

Anterior approach results in better operative and survival outcomes compared with the conventional approach in patients with large hepatocellular carcinoma (HCC), and the liver hanging maneuver (LHM) is commonly applied to right hepatectomies as an adjunct to the anterior approach. It has several advantages, including better control of bleeding, protection of the inferior vena cava, exposure during deeper parenchymal dissection, rapid transaction, and guidelines for the direction of transection, but the LHM is considered technically difficult and precarious by some surgeons because of the retrohepatic dissection, and it is still limited by several factors. The technique is absolutely contraindicated in tumors infiltrating the IVC, and anterior approach still 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 conjunction with the LHM.


Condition Intervention
Anterior Approach Liver Resection
Blood Loss
External Causes of Morbidity and Mortality
 Procedure: infrahepatic IVC clamping
Procedure: liver hanging maneuver

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:A Prospective Randomized Controlled Study

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: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
AA+IVC Clamping Procedure: infrahepatic IVC clamping
anterior approach combined with infrahepatic IVC clamping in right liver resection.
Other Name: group Ⅰ
AA+LHM Procedure: liver hanging maneuver
anterior approach in conjunction with the LHM in right liver resection.
Other Name: group Ⅱ

  Eligibility

Ages Eligible for Study:   17 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 hepatic masses 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608386

Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
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: May 26, 2012
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013