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

• ClinicalTrials.gov Identifier: NCT01180088
• Recruitment Status: Unknown
• First Posted: August 11, 2010
• Last Update Posted: August 11, 2010
• Sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino
• Information provided by: Azienda Ospedaliera Ordine Mauriziano di Torino

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Liver Neoplasm	Procedure: RIGHT HEPATECTOMY WITH CLASSIC APPROACH	Not Applicable

Detailed 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%).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy: A Randomized Trial
• Study Start Date: August 2010
• Estimated Primary Completion Date: September 2010
• Estimated Study Completion Date: August 2011

Arms and Interventions

Arm

Intervention/treatment

Experimental: ANTERIOR APPROACH; SURGICAL TECHNIQUE

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

Outcome Measures

Primary Outcome Measures :

1. OVERALL BLOOD LOSS [ Time Frame: UP TO 7 DAYS ]

Secondary Outcome Measures :

1. BLOOD TRANSFUSION RATE [ Time Frame: WITHIN 24 HOURS ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Italy

Ospedale Mauriziano di Torino

Turin, Italy, 10100

Contact: Alessandro Ferrero, MD 00390115082590 aferrero@mauriziano.it

Principal Investigator: Lorenzo Capussotti, MD

Sponsors and Collaborators

Azienda Ospedaliera Ordine Mauriziano di Torino

Investigators

• Principal Investigator: Lorenzo Capussotti, MD; Ospedale Mauriziano di Torino

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Capussotti L, Ferrero A, Russolillo N, Langella S, Lo Tesoriere R, Viganò L. Routine anterior approach during right hepatectomy: results of a prospective randomised controlled trial. J Gastrointest Surg. 2012 Jul;16(7):1324-32. doi: 10.1007/s11605-012-1894-6. Epub 2012 May 9.

• Responsible Party: Lorenzo Capussotti MD, Azienda Ospedaliera Ordine Mauriziano di Torino
• ClinicalTrials.gov Identifier: NCT01180088
• Other Study ID Numbers: AA001
• First Posted: August 11, 2010
• Last Update Posted: August 11, 2010
• Last Verified: August 2010

Keywords provided by Azienda Ospedaliera Ordine Mauriziano di Torino:

LIVER TUMOURS

Additional relevant MeSH terms:

Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases