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
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- intraoperative total blood loss [ Time Frame: participants will be followed for the duration of the entire operation,an expected average of 140 minutes ]
- operation time [ Time Frame: the duration of the entire operation,an expected average of 140 minutes ]
- intraoperative CVP value [ Time Frame: participants will be followed for the duration of the parenchymal transection,an expected average of 20 minutes ]
- morbidity and mortality [ Time Frame: participants will be followed for the duration of the postoperative hospital stay,an expected average of 15 days ]
- postoperative hepatorenal function [ Time Frame: postoperative day 1,3 and 7 ]
- postoperative hospital stay [ Time Frame: the duration of the postoperative hospital stay,an expected average of 15 days ]
- disease-free survival duration and overall survival duration [ Time Frame: the duration from operation to recurrence or death,an expected average of 3 years ]
- blood loss during parenchymal transection [ Time Frame: the duration of the parenchymal transection,an expected average of 20 minutes ]
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
|Study Director:||Jiamei Yang, MD||Eastern Hepatobiliary Surgery Hospital|
|Principal Investigator:||Chengjun Sui, MD||Eastern Hepatobiliary Surgery Hospital|