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

Not Applicable

• Conditions: Blood Loss; Surgical Approach & Incisions
• Interventions: Procedure: IVC clamping

• Registration Number: NCT01608386
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-22
• Study First Submitted QC: 2012-05-26
• Study First Posted: 2012-05-31
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-06
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anterior approach+IVC clamping	IVC clamping	Use anterior approach combined with infrahepatic Inferior Vena Cava clamping in right hepatectomy for HCC patients.

Primary Outcome Measures

Name	Time	Method
intraoperative total blood loss	participants will be followed for the duration of the entire operation,an expected average of 140 minutes

Secondary Outcome Measures

Name	Time	Method
morbidity and mortality	participants will be followed for the duration of the postoperative hospital stay,an expected average of 15 days
postoperative hepatorenal function	postoperative day 1,3 and 7
operation time	the duration of the entire operation,an expected average of 140 minutes
intraoperative CVP value	participants will be followed for the duration of the parenchymal transection,an expected average of 20 minutes
postoperative hospital stay	the duration of the postoperative hospital stay,an expected average of 15 days
disease-free survival duration and overall survival duration	the duration from operation to recurrence or death,an expected average of 3 years
blood loss during parenchymal transection	the duration of the parenchymal transection,an expected average of 20 minutes