Liver FailureNCT02846441
Interstage Assessment of Remnant Liver Function in ALPPS
An observational study of Liver Failure, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure
- What is being tested?
- hepatobiliary scintigraphy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- Jul 2011to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted to ALPPS surgery at the Hospital Italiano between 2011 and 2016.
Who may be able to join
- Hepatobiliary scintigraphy performed between stages in patients submitted to ALPPS surgery
- Aged ≥18
Who cannot join
- Known allergy to Hida derivatives
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires
About this study
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?
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.
Read the 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.
- Conditions
- Liver Failure
- Being tested
- hepatobiliary scintigraphy
- Keywords
- posthepatectomy liver failure, ALPPS, hepatobiliary scintigraphy, SPECT, mebrofenin
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatobiliary scintigraphyProcedure or surgery
Also called spect
99mTc-mebrofenin hepatobiliary scintigraphy with single photon emission computed tomography (SPECT)
What is being measured
The primary outcome is the main question the study is designed to answer.
posthepatectomy liver failure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJul 2011
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, eduardo de santibanes, Hospital Italiano de Buenos Aires
- Investigators
- eduardo de santibanes, MD, PhD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846441
- Sponsor's protocol ID
- 2900
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 1539327de 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.
PubMed 19937195de 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.
PubMed 20080899Schadde 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.
PubMed 26583666Rahbari 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.
PubMed 21236455Schnitzbauer 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.
PubMed 22330038
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02846441
- Acronym / sponsor ID
- 2900
- Conditions
- Liver Failure
- Keywords
- posthepatectomy liver failure, ALPPS, hepatobiliary scintigraphy, SPECT, mebrofenin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to ALPPS surgery at the Hospital Italiano between 2011 and 2016.
Key inclusion criteria (2 listed)
- Hepatobiliary scintigraphy performed between stages in patients submitted to ALPPS surgery
- Aged ≥18
Key exclusion criteria (1 listed)
- Known allergy to Hida derivatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatobiliary scintigraphyAlso: spect99mTc-mebrofenin hepatobiliary scintigraphy with single photon emission computed tomography (SPECT) | Procedure or surgery | – |
Primary outcome
posthepatectomy liver failure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Background: PubMed 1539327Ekman 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.
- Background: PubMed 19937195de 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.
- Background: PubMed 20080899de 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.
- Background: PubMed 26583666Schadde 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.
- Background: PubMed 21236455Rahbari 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.
- Background: PubMed 22330038Schnitzbauer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
eduardo de santibanes, MD, PhD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
posthepatectomy liver failure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846441, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.