NCT01180088

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 11, 2010

Status Verified

August 1, 2010

Enrollment Period

1 month

First QC Date

August 9, 2010

Last Update Submit

August 10, 2010

Conditions

Liver Neoplasm

Keywords

LIVER TUMOURS

Outcome Measures

Primary Outcomes (1)

  • OVERALL BLOOD LOSS

    UP TO 7 DAYS

Secondary Outcomes (1)

  • BLOOD TRANSFUSION RATE

    WITHIN 24 HOURS

Study Arms (1)

ANTERIOR APPROACH

EXPERIMENTAL

SURGICAL TECHNIQUE

Procedure: RIGHT HEPATECTOMY WITH CLASSIC APPROACH

Interventions

RIGHT HEPATECTOMY WITH CLASSIC APPROACHPROCEDURE

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

Also known as: Right Hepatectomy
ANTERIOR APPROACH

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • resection of S1
  • resection of bile duct
  • infiltration of inferior vena cava
  • America Society of Anesthesiologists (ASA) grade IV
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Mauriziano di Torino

Turin, 10100, Italy

Location

Related Publications (4)

  • 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.

    PMID: 8661837BACKGROUND

  • 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.

    PMID: 16858181BACKGROUND

  • 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.

    PMID: 10862191BACKGROUND

  • 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.

    PMID: 22570073DERIVED

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Lorenzo Capussotti, MD

    Ospedale Mauriziano di Torino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 11, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2010

Study Completion

August 1, 2011

Last Updated

August 11, 2010

Record last verified: 2010-08

Locations

IT(1)