Clinical trial NCT01608386: A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping
Official title: Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping Right Hepatic Resection for Large Hepatocellular Carcinoma: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Approach & Incisions
Blood Loss
Keywords: Anterior approach
infrahepatic inferior vena cava clamping
hepatic resection
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Xiamen University
First posted: 2012-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: intraoperative total blood loss
timeFrame: participants will be followed for the duration of the entire operation,an expected average of 140 minutes
Secondary outcomes:
measure: operation time
timeFrame: the duration of the entire operation,an expected average of 140 minutes
measure: intraoperative CVP value
timeFrame: participants will be followed for the duration of the parenchymal transection,an expected average of 20 minutes
measure: morbidity and mortality
timeFrame: participants will be followed for the duration of the postoperative hospital stay,an expected average of 15 days
measure: postoperative hepatorenal function
timeFrame: postoperative day 1,3 and 7
measure: postoperative hospital stay
timeFrame: the duration of the postoperative hospital stay,an expected average of 15 days
measure: disease-free survival duration and overall survival duration
timeFrame: the duration from operation to recurrence or death,an expected average of 3 years
measure: blood loss during parenchymal transection
timeFrame: the duration of the parenchymal transection,an expected average of 20 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Jiamei Yang, MD
role: STUDY_DIRECTOR
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Chengjun Sui, MD
role: PRINCIPAL_INVESTIGATOR
References: