Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy

Liver Neoplasm Clinical Trial

— AA  

Official title:

Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy: A Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01180088
• Other study ID #: AA001
• Status: Not yet recruiting
• Phase: N/A
• First received: August 9, 2010
• Last updated: August 10, 2010
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2010
• Source: Azienda Ospedaliera Ordine Mauriziano di Torino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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%).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Liver Neoplasm
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Mauriziano di Torino	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Ordine Mauriziano di Torino

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Lai EC, Fan ST, Lo CM, Chu KM, Liu CL. Anterior approach for difficult major right hepatectomy. World J Surg. 1996 Mar-Apr;20(3):314-7; discussion 318. — View Citation

Liu CL, Fan ST, Cheung ST, Lo CM, Ng IO, Wong J. Anterior approach versus conventional approach right hepatic resection for large hepatocellular carcinoma: a prospective randomized controlled study. Ann Surg. 2006 Aug;244(2):194-203. — View Citation

Liu CL, Fan ST, Lo CM, Tung-Ping Poon R, Wong J. Anterior approach for major right hepatic resection for large hepatocellular carcinoma. Ann Surg. 2000 Jul;232(1):25-31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OVERALL BLOOD LOSS		UP TO 7 DAYS	No
Secondary	BLOOD TRANSFUSION RATE		WITHIN 24 HOURS	No