NCT01483859

Brief Summary

Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France) is a newly introduced noninvasive tool that generates an elastic wave using a vibrator applied to the thoracic wall at the level of the right lobe of the liver and measures the prolongation velocity of the wave, which is directly associated with liver stiffness (LS). Although recent advances in surgical techniques and perioperative management have made with established perioperative management have now made it possible to perform hepatectomies as a safe procedure with minimum mortality, the possibility of massive blood loss and resultant transfusion during hepatectomy still exist. The objective of this research was to identify the role of liver stiffness measurement for the prediction of intraoperative blood loss and postoperative recovery after elective right hepatectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 16, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

November 24, 2011

Last Update Submit

July 14, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • The correlation between the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy

    The investigators will investigate the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy through chart review. The investigators will analyze the correlation between the value of liver stiffness measurement and intraoperative blood loss during right hepatectomy

    Participants will be followed for perioperative period, approximate 6 weeks through chart review.

Study Arms (1)

right hepatectomy with preoperative LSM

OTHER

patients undergoing right hepatectomy with preoperative LSM between August 2007 and July 2011

Other: preoperative liver stiffness measurement

Interventions

Liver stiffness measurement (LSM) using Fibroscan is a newly introduced noninvasive tool that generates an elastic wave using a vibrator applied to the thoracic wall at the level of the right lobe of the liver and measures the prolongation velocity of the wave, which is directly associated with liver stiffness (LS).

Also known as: Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France)
right hepatectomy with preoperative LSM

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing right hepatectomy between August 2007 and July 2011

You may not qualify if:

  • patients undergoing right hepatectomy without preoperative liver stiffness measurement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 24, 2011

First Posted

December 1, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

July 16, 2015

Record last verified: 2015-07

Locations