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

Blood Loss Clinical Trial

— AA+IVC  

Official title:

Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping Right Hepatic Resection for Large Hepatocellular Carcinoma: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01608386
• Other study ID #: EHBHKY2012-002-16
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 22, 2012
• Last updated: August 5, 2015
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Surgical Approach & Incisions

Intervention

Procedure:
• IVC clamping
in right hepatectomy,use anterior approach and infrahepatic Inferior Vena Cava clamping.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Hepatobiliary Surgery Hospital	The First Affiliated Hospital of Xiamen University

Outcome

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