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

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ClinicalTrials.gov Identifier: NCT01180088
Recruitment Status : Unknown
Verified August 2010 by Azienda Ospedaliera Ordine Mauriziano di Torino.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2010
Last Update Posted : August 11, 2010
Sponsor:
Information provided by:
Azienda Ospedaliera Ordine Mauriziano di Torino

Tracking Information
First Submitted Date  ICMJE August 9, 2010
First Posted Date  ICMJE August 11, 2010
Last Update Posted Date August 11, 2010
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
OVERALL BLOOD LOSS [ Time Frame: UP TO 7 DAYS ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2010)
BLOOD TRANSFUSION RATE [ Time Frame: WITHIN 24 HOURS ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy
Official Title  ICMJE Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy: A Randomized Trial
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%).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Neoplasm
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: ANTERIOR APPROACH
SURGICAL TECHNIQUE
Intervention: Procedure: RIGHT HEPATECTOMY WITH CLASSIC APPROACH
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 10, 2010)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2011
Estimated Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01180088
Other Study ID Numbers  ICMJE AA001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lorenzo Capussotti MD, Azienda Ospedaliera Ordine Mauriziano di Torino
Study Sponsor  ICMJE Azienda Ospedaliera Ordine Mauriziano di Torino
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lorenzo Capussotti, MD Ospedale Mauriziano di Torino
PRS Account Azienda Ospedaliera Ordine Mauriziano di Torino
Verification Date August 2010

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