Clinical trial NCT01180088: Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy
Official title: Effectiveness of Routine Application Of Anterior Approach During Right Hepatectomy: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Neoplasm
Keywords: LIVER TUMOURS
Lead sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%).

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

Primary outcomes:
measure: OVERALL BLOOD LOSS
timeFrame: UP TO 7 DAYS
Secondary outcomes:
measure: BLOOD TRANSFUSION RATE
timeFrame: WITHIN 24 HOURS
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Ospedale Mauriziano di Torino
Study officials:
affiliation: Ospedale Mauriziano di Torino
name: Lorenzo Capussotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.