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
  Purpose

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 Intervention
Liver Neoplasm
Procedure: RIGHT HEPATECTOMY WITH CLASSIC APPROACH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Ordine Mauriziano di Torino:

Primary Outcome Measures:
  • OVERALL BLOOD LOSS [ Time Frame: UP TO 7 DAYS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • BLOOD TRANSFUSION RATE [ Time Frame: WITHIN 24 HOURS ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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%).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180088

Locations
Italy
Ospedale Mauriziano di Torino Recruiting
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lorenzo Capussotti MD, Azienda Ospedaliera Ordine Mauriziano di Torino
ClinicalTrials.gov Identifier: NCT01180088     History of Changes
Other Study ID Numbers: AA001
Study First Received: August 9, 2010
Last Updated: August 10, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera Ordine Mauriziano di Torino:
LIVER TUMOURS

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 23, 2014