Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy

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 April 10, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01180088