Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy

NCT ID: NCT01180088

Last Updated: 2010-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-08-31

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%).

Conditions

Liver Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ANTERIOR APPROACH

SURGICAL TECHNIQUE

Group Type: EXPERIMENTAL

RIGHT HEPATECTOMY WITH CLASSIC APPROACH

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

Right Hepatectomy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Ordine Mauriziano di Torino

OTHER

Sponsor Role: lead

Responsible Party

Azienda Ospedaliera Ordine Mauriziano di Torino

Principal Investigators

Lorenzo Capussotti, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Mauriziano di Torino

Locations

Ospedale Mauriziano di Torino

Turin, , Italy

Countries

Italy

Facility Contacts

Alessandro Ferrero, MD

Role: primary

aferrero@mauriziano.it

00390115082590

References

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.

Reference Type: BACKGROUND

PMID: 8661837 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16858181 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10862191 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22570073 (View on PubMed)

Other Identifiers

AA001

Identifier Type: -

Identifier Source: org_study_id