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

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ClinicalTrials.gov Identifier: NCT01608386
Recruitment Status : Unknown
Verified August 2015 by Chengjun Sui,MD, Eastern Hepatobiliary Surgery Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 31, 2012
Last Update Posted : August 6, 2015
Sponsor:
Collaborator:
The First Affiliated Hospital of Xiamen University
Information provided by (Responsible Party):
Chengjun Sui,MD, Eastern Hepatobiliary Surgery Hospital

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.


Condition or disease Intervention/treatment Phase
Surgical Approach & Incisions Blood Loss Procedure: IVC clamping Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

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.



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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015

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