Clinical trial NCT02846441: Interstage Assessment of Remnant Liver Function in ALPPS
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Failure
Keywords: posthepatectomy liver failure
ALPPS
hepatobiliary scintigraphy
SPECT
mebrofenin
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to ALPPS surgery at the Hospital Italiano between 2011 and 2016.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Hepatobiliary scintigraphy performed between stages in patients submitted to ALPPS surgery
* Aged ≥18

Exclusion Criteria:

* Known allergy to Hida derivatives

Primary outcomes:
measure: posthepatectomy liver failure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: eduardo de santibanes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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