A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping

NCT ID: NCT01608386

Last Updated: 2015-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Surgical Approach & Incisions; Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

anterior approach+IVC clamping

Use anterior approach combined with infrahepatic Inferior Vena Cava clamping in right hepatectomy for HCC patients.

Group Type: EXPERIMENTAL

IVC clamping

Intervention Type: PROCEDURE

in right hepatectomy,use anterior approach and infrahepatic Inferior Vena Cava clamping.

anterior approach

Only use anterior approach in right hepatectomy for HCC patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

IVC clamping

in right hepatectomy,use anterior approach and infrahepatic Inferior Vena Cava clamping.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: collaborator

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chengjun Sui,MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiamei Yang, MD

Role: STUDY_DIRECTOR

Eastern Hepatobiliary Surgery Hospital

Chengjun Sui, MD

Role: PRINCIPAL_INVESTIGATOR

Eastern Hepatobiliary Surgery Hospital

Other Identifiers

EHBHKY2012-002-16

Identifier Type: -

Identifier Source: org_study_id