Interstage Assessment of Remnant Liver Function in ALPPS

NCT02846441 | Completed

• 1 other identifier: 2900
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Failure

Keywords

posthepatectomy liver failure; ALPPS; hepatobiliary scintigraphy; SPECT; mebrofenin

Outcome Measures

Primary Outcomes (1)

• posthepatectomy liver failure

  3 months

Interventions

hepatobiliary scintigraphy PROCEDURE

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

Also known as: spect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients submitted to ALPPS surgery at the Hospital Italiano between 2011 and 2016.

You may qualify if:

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

You may not qualify if:

• Known allergy to Hida derivatives

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires, Argentina

Location

Related Publications (6)

• 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.

  PMID: 1539327 BACKGROUND

• 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.

  PMID: 19937195 BACKGROUND

• 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.

  PMID: 20080899 BACKGROUND

• 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.

  PMID: 26583666 BACKGROUND

• 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.

  PMID: 21236455 BACKGROUND

• 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.

  PMID: 22330038 BACKGROUND

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• eduardo de santibanes, MD, PhD

  Hospital Italiano de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 27, 2016
• Study Start: July 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)