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

Primary Purpose

Liver Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
RIGHT HEPATECTOMY WITH CLASSIC APPROACH
Sponsored by
Azienda Ospedaliera Ordine Mauriziano di Torino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Neoplasm focused on measuring LIVER TUMOURS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Mauriziano di Torino

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ANTERIOR APPROACH

Arm Description

SURGICAL TECHNIQUE

Outcomes

Primary Outcome Measures

OVERALL BLOOD LOSS

Secondary Outcome Measures

BLOOD TRANSFUSION RATE

Full Information

First Posted
August 9, 2010
Last Updated
August 10, 2010
Sponsor
Azienda Ospedaliera Ordine Mauriziano di Torino
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1. Study Identification

Unique Protocol Identification Number
NCT01180088
Brief Title
Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy
Acronym
AA
Official Title
Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Azienda Ospedaliera Ordine Mauriziano di Torino

4. Oversight

Data Monitoring Committee
No

5. 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.
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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasm
Keywords
LIVER TUMOURS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ANTERIOR APPROACH
Arm Type
Experimental
Arm Description
SURGICAL TECHNIQUE
Intervention Type
Procedure
Intervention Name(s)
RIGHT HEPATECTOMY WITH CLASSIC APPROACH
Other Intervention Name(s)
Right Hepatectomy
Intervention Description
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
Primary Outcome Measure Information:
Title
OVERALL BLOOD LOSS
Time Frame
UP TO 7 DAYS
Secondary Outcome Measure Information:
Title
BLOOD TRANSFUSION RATE
Time Frame
WITHIN 24 HOURS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Capussotti, MD
Organizational Affiliation
Ospedale Mauriziano di Torino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Mauriziano di Torino
City
Turin
ZIP/Postal Code
10100
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Ferrero, MD
Phone
00390115082590
Email
aferrero@mauriziano.it
First Name & Middle Initial & Last Name & Degree
Lorenzo Capussotti, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
8661837
Citation
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. doi: 10.1007/s002689900050.
Results Reference
background
PubMed Identifier
16858181
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. doi: 10.1097/01.sla.0000225095.18754.45.
Results Reference
background
PubMed Identifier
10862191
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. doi: 10.1097/00000658-200007000-00004.
Results Reference
background
PubMed Identifier
22570073
Citation
Capussotti L, Ferrero A, Russolillo N, Langella S, Lo Tesoriere R, Vigano 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.
Results Reference
derived

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Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy

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