Interstage Assessment of Remnant Liver Function in ALPPS

NCT ID: NCT02846441

Last Updated: 2016-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Liver Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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hepatobiliary scintigraphy

99mTc-mebrofenin hepatobiliary scintigraphy with single photon emission computed tomography (SPECT)

Intervention Type PROCEDURE

Other Intervention Names

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spect

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Known allergy to Hida derivatives
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Italiano de Buenos Aires

OTHER

Sponsor Role lead

Responsible Party

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eduardo de santibanes

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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eduardo de santibanes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Italiano de Buenos Aires

Locations

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Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires, Argentina

Site Status

Countries

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Argentina

References

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Ekman M, Fjalling M, Holmberg S, Person H. IODIDA clearance rate: a method for measuring hepatocyte uptake function. Transplant Proc. 1992 Feb;24(1):387-8. No abstract available.

Reference Type BACKGROUND
PMID: 1539327 (View on PubMed)

de Graaf W, van Lienden KP, Dinant S, Roelofs JJ, Busch OR, Gouma DJ, Bennink RJ, van Gulik TM. Assessment of future remnant liver function using hepatobiliary scintigraphy in patients undergoing major liver resection. J Gastrointest Surg. 2010 Feb;14(2):369-78. doi: 10.1007/s11605-009-1085-2.

Reference Type BACKGROUND
PMID: 19937195 (View on PubMed)

de Graaf W, van Lienden KP, van Gulik TM, Bennink RJ. (99m)Tc-mebrofenin hepatobiliary scintigraphy with SPECT for the assessment of hepatic function and liver functional volume before partial hepatectomy. J Nucl Med. 2010 Feb;51(2):229-36. doi: 10.2967/jnumed.109.069724. Epub 2010 Jan 15.

Reference Type BACKGROUND
PMID: 20080899 (View on PubMed)

Schadde E, Raptis DA, Schnitzbauer AA, Ardiles V, Tschuor C, Lesurtel M, Abdalla EK, Hernandez-Alejandro R, Jovine E, Machado M, Malago M, Robles-Campos R, Petrowsky H, Santibanes ED, Clavien PA. Prediction of Mortality After ALPPS Stage-1: An Analysis of 320 Patients From the International ALPPS Registry. Ann Surg. 2015 Nov;262(5):780-5; discussion 785-6. doi: 10.1097/SLA.0000000000001450.

Reference Type BACKGROUND
PMID: 26583666 (View on PubMed)

Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.

Reference Type BACKGROUND
PMID: 21236455 (View on PubMed)

Schnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Horbelt R, Kroemer A, Loss M, Rummele P, Scherer MN, Padberg W, Konigsrainer A, Lang H, Obed A, Schlitt HJ. Right portal vein ligation combined with in situ splitting induces rapid left lateral liver lobe hypertrophy enabling 2-staged extended right hepatic resection in small-for-size settings. Ann Surg. 2012 Mar;255(3):405-14. doi: 10.1097/SLA.0b013e31824856f5.

Reference Type BACKGROUND
PMID: 22330038 (View on PubMed)

Other Identifiers

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2900

Identifier Type: -

Identifier Source: org_study_id

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