Interstage Assessment of Remnant Liver Function in ALPPS

Liver Failure Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846441
• Other study ID #: 2900
• Status: Completed
• Phase: N/A
• First received: July 22, 2016
• Last updated: July 27, 2016
• Start date: July 2011
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Hospital Italiano de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hepatobiliary scintigraphy performed between stages in patients submitted to ALPPS surgery

• Aged =18

Exclusion Criteria:

• Known allergy to Hida derivatives

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Liver Failure

Intervention

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

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Italiano de Buenos Aires

Country where clinical trial is conducted

Argentina, 

References & Publications (6)

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. — View Citation

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. — View Citation

Ekman M, Fjälling M, Holmberg S, Person H. IODIDA clearance rate: a method for measuring hepatocyte uptake function. Transplant Proc. 1992 Feb;24(1):387-8. — View Citation

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, Büchler 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. — View Citation

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. — View Citation

Schnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Hörbelt R, Kroemer A, Loss M, Rümmele P, Scherer MN, Padberg W, Königsrainer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	posthepatectomy liver failure		3 months	No