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Trial Title:
Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy
NCT ID:
NCT01180088
Condition:
Liver Neoplasm
Conditions: Official terms:
Liver Neoplasms
Conditions: Keywords:
LIVER TUMOURS
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
RIGHT HEPATECTOMY WITH CLASSIC APPROACH
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
Arm group label:
ANTERIOR APPROACH
Other name:
Right Hepatectomy
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%).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ospedale Mauriziano di Torino
Address:
City:
Turin
Zip:
10100
Country:
Italy
Contact:
Last name:
Alessandro Ferrero, MD
Phone:
00390115082590
Email:
aferrero@mauriziano.it
Investigator:
Last name:
Lorenzo Capussotti, MD
Email:
Principal Investigator
Start date:
August 2010
Completion date:
August 2011
Lead sponsor:
Agency:
Azienda Ospedaliera Ordine Mauriziano di Torino
Agency class:
Other
Source:
Azienda Ospedaliera Ordine Mauriziano di Torino
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01180088
