Interstage Assessment of Remnant Liver Function in ALPPS

Sponsor
Hospital Italiano de Buenos Aires (Other)
Overall Status
Completed
CT.gov ID
NCT02846441
Collaborator
(none)
20
1
59
0.3

Study Details

Study Description

Brief Summary

Post-hepatectomy liver failure is one of the most feared complications by hepatic surgeons. When size of the future liver remnant (FLR) is regarded to be not sufficient to sustain post-hepatectomy liver function, techniques as preoperative portal vein embolization or two-stage hepatectomy/associating liver partition and portal vein ligation (ALPPS) can be performed. ALPPS induces rapid and extensive hypertrophy by portal vein ligation and in situ liver splitting. To date, feasibility of the second stage of ALPPS has been assessed only on the basis of standardized future liver remnant or future liver remnant on body weight. However, decrease of liver function between stages, measured by means of laboratory parameters, has been demonstrated to be associated with higher 90-day mortality, regardless of FLR volume. In other words, this volumetric increase may not reflect the increase of liver function.

Condition or Disease Intervention/Treatment Phase
  • Procedure: hepatobiliary scintigraphy

Detailed Description

The aim of this study is to determine the predictive value of hepatobiliary scintigraphy with 99mTc-mebrofenin between stages in ALPPS, in assessing risk of postoperative liver failure and liver failure-related mortality after completion of stage 2.

Study Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Interstage Assessment of Remnant Liver Function in ALPPS: Can SPECT Hepatobiliary Scintigraphy Provide Any Additional Value in Predicting Risk of Posthepatectomy Liver Failure?
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Outcome Measures

Primary Outcome Measures

  1. posthepatectomy liver failure [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Hepatobiliary scintigraphy performed between stages in patients submitted to ALPPS surgery

  • Aged ≥18

Exclusion Criteria:
  • Known allergy to Hida derivatives

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Italiano de Buenos Aires Buenos Aires Argentina

Sponsors and Collaborators

  • Hospital Italiano de Buenos Aires

Investigators

  • Principal Investigator: eduardo de santibanes, MD, PhD, Hospital Italiano de Buenos Aires

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
eduardo de santibanes, MD, PhD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT02846441
Other Study ID Numbers:
  • 2900
First Posted:
Jul 27, 2016
Last Update Posted:
Jul 28, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by eduardo de santibanes, MD, PhD, Hospital Italiano de Buenos Aires
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2016