Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy (AA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Azienda Ospedaliera Ordine Mauriziano di Torino.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Azienda Ospedaliera Ordine Mauriziano di Torino
ClinicalTrials.gov Identifier:
NCT01180088
First received: August 9, 2010
Last updated: August 10, 2010
Last verified: August 2010

August 9, 2010
August 10, 2010
August 2010
September 2010   (final data collection date for primary outcome measure)
OVERALL BLOOD LOSS [ Time Frame: UP TO 7 DAYS ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01180088 on ClinicalTrials.gov Archive Site
BLOOD TRANSFUSION RATE [ Time Frame: WITHIN 24 HOURS ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy
Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy: A Randomized Trial

The aim of this study was to evaluated the advantages of routine application of the anterior approach in patients scheduled to right hepatectomy or extended right hepatectomy, without infiltration of segment 1, inferior vena cava or main bile duct.

Mobilization of the liver during right hepatectomy with classic approach is performed before parenchymal transection. In this phase severe bleeding may occur due to laceration of the inferior vena cava (IVC) wall, rupture or ligation falling off the hepatic short vein (HSV) or bleeding from the right liver attachments. Besides, the twisting of the portal pedicle during mobilization can render the left hepatic lobe ischemic for transient interruption of the hepatopetal flow. These events are more frequent in case of large hepatic lesions (mainly HCC) that involves surrounding structures (such as diaphragm). Two of the most important factors that affect the postoperative course of patients undergoing liver resections are indeed intraoperative bleeding and postoperative liver dysfunction. For these reasons Lai et al proposed anterior approach as alternative to classic right hepatectomy. In this case liver mobilization is performed only at the end of parenchymal transection, when all vascular connections are already interrupted. Liu et al published the results of a retrospective study in which 54 patients with, right sided HCC greater than 5 cm underwent right hepatectomy using the anterior approach technique. The anterior approach group had significantly less intraoperative blood loss, less need of blood transfusion and a lower hospital mortality rate. The same group reported results of a prospective randomized controlled study analyzing 120 patients with large (>5 cm) right liver HCC. The overall operative blood loss, morbidity, and duration of hospital stay were comparable in both groups. However, a higher number of patients in classic approach group experienced mayor operative blood loss (> 2000 cc) and required blood transfusions (8.3% vs. 28.3%).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Neoplasm
Procedure: RIGHT HEPATECTOMY WITH CLASSIC APPROACH
The right portal branch and the right branch of the hepatic artery were identified, dissected and divided. Extraparenchymal ligation of pedicles for Sg4 was performed in case of extended right hepatectomy. The falciform and the right triangular ligaments were sectioned and the right liver up to the retrohepatic vena cava was totally mobilized by section and sutures of the accessory right hepatic veins. The right hepatic vein was controlled in an extrahepatic plane and encircled with a tape. At the end of parenchymal transection right hepatic vein was sectioned with endovascular stapler. The right bile duct and middle hepatic vein (in case of extended right hepatectomy) were divided intraparenchymally
Other Name: Right Hepatectomy
Experimental: ANTERIOR APPROACH
SURGICAL TECHNIQUE
Intervention: Procedure: RIGHT HEPATECTOMY WITH CLASSIC APPROACH

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
August 2011
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients between 18 and 80 years
  • patients scheduled to right hepatectomy or extended right hepatectomy
  • the future remnant liver (FRL) ≥ 25% in patients with a normal liver or ≥ 30% in those with chronic liver disease
  • indocyanine green retention rate (ICG) at 15 minutes ≤ 10% in cirrhotic patients

Exclusion Criteria:

  • resection of S1
  • resection of bile duct
  • infiltration of inferior vena cava
  • America Society of Anesthesiologists (ASA) grade IV
  • Emergency surgery
Both
18 Years to 80 Years
No
Italy
 
NCT01180088
AA001
No
Lorenzo Capussotti MD, Azienda Ospedaliera Ordine Mauriziano di Torino
Azienda Ospedaliera Ordine Mauriziano di Torino
Not Provided
Principal Investigator: Lorenzo Capussotti, MD Ospedale Mauriziano di Torino
Azienda Ospedaliera Ordine Mauriziano di Torino
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP