Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies
SCINTIVOL
Predictive Value of Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies Stretches of 4 or More Segments on Non-cirrhotic Liver
2 other identifiers
interventional
326
1 country
12
Brief Summary
Extended hepatectomies of 4 or more segments are complicated by high rates of morbidity and mortality, mainly related to hepatic liver failure. Nowadays, preoperative assessment of the future remnant liver is just performed through its volumetric measurement by computed tomography. Nevertheless, this volumetric assessment does not reflect the hepatocellular function of the future remnant liver that can be disturbed in case of vascular and/or biliary obstruction, chemotherapy-induced liver injuries or steatosis in overweight patients. Literature data (albeit originating from a single centre in Europe) have suggested that (99m)Tc-mebrofenin hepatobiliary scintigraphy could be useful in evaluating the function of the future remnant liver. The aim of this prospective multicentric study is to determine the predictive value of hepatobiliary scintigraphy in assessing the risk of postoperative liver failure of extended hepatectomies of 4 or more segments in noncirrhotic liver.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 8, 2015
CompletedFirst Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2021
CompletedApril 21, 2026
April 1, 2025
6 years
April 25, 2016
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hepatic insufficiency
ISGLS criteria : a definition and grading by the International Study Group of Liver Surgery (ISGLS)of the Posthepatectomy liver failure:
at 3 months
Secondary Outcomes (4)
Postoperative morbi-mortality
at 3 months
Duration of intensive care unit stay and of hospitalization
3 months
Histological analysis of the non tumoral liver parenchyma
at 3 months
Inter-centre reproducibility of the hepatobiliary scintigraphy
at 3 months
Study Arms (1)
Extended hepatectomy
OTHERHepatic Scintigraphy
Interventions
hepatobiliary scintigraphy with functional assessment of the future remnant liver before an extended hepatectomy of 4 or more segments
Eligibility Criteria
You may qualify if:
- Noncirrhotic liver
- Benign or malignant liver tumor
- Anatomic hepatic resection ≥ 4 segments
- Aged ≥18
- ASA Score ≤3
- Signed informed consent
- Presence of contraception in non-menopausal women
You may not qualify if:
- Cirrhosis
- Absence of preoperative biliary drainage in case of preoperative jaundice
- Patient refusal
- Absence of affiliation to Social Security
- Body weight above 230kg
- Known allergy to Hida derivatives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Ministry of Health, Francecollaborator
Study Sites (12)
Hôpital Nord, CHU
Amiens, France
CHU
Bordeaux, France
Hopital Estaing - Chu63 - Clermont Ferrand
Clermont-Ferrand, France
CHU
Grenoble, France
CHRU, Hôpital Claude Huriez
Lille, France
Centre Leon Berard - Lyon 08
Lyon, 69008, France
Hopital Croix-Rousse - Hcl - Lyon 04
Lyon, 69008, France
CHU
Marseille, France
Chru Nancy - Hopitaux de Brabois
Nancy, France
AP-HPHôpital Beaujon,
Paris, France
CHU
Rouen, France
CHU
Toulouse, France
Related Publications (5)
Bennink RJ, Tulchinsky M, de Graaf W, Kadry Z, van Gulik TM. Liver function testing with nuclear medicine techniques is coming of age. Semin Nucl Med. 2012 Mar;42(2):124-37. doi: 10.1053/j.semnuclmed.2011.10.003.
PMID: 22293167RESULTde Graaf W, Heger M, Spruijt O, Maas A, de Bruin K, Hoekstra R, Bennink RJ, van Gulik TM. Quantitative assessment of liver function after ischemia-reperfusion injury and partial hepatectomy in rats. J Surg Res. 2012 Jan;172(1):85-94. doi: 10.1016/j.jss.2010.06.038. Epub 2010 Jul 21.
PMID: 20869070RESULTde Graaf W, Bennink RJ, Vetelainen R, van Gulik TM. Nuclear imaging techniques for the assessment of hepatic function in liver surgery and transplantation. J Nucl Med. 2010 May;51(5):742-52. doi: 10.2967/jnumed.109.069435. Epub 2010 Apr 15.
PMID: 20395336RESULTde Graaf W, Hausler S, Heger M, van Ginhoven TM, van Cappellen G, Bennink RJ, Kullak-Ublick GA, Hesselmann R, van Gulik TM, Stieger B. Transporters involved in the hepatic uptake of (99m)Tc-mebrofenin and indocyanine green. J Hepatol. 2011 Apr;54(4):738-45. doi: 10.1016/j.jhep.2010.07.047. Epub 2010 Oct 1.
PMID: 21163547RESULTde Graaf W, van Lienden KP, van den Esschert JW, Bennink RJ, van Gulik TM. Increase in future remnant liver function after preoperative portal vein embolization. Br J Surg. 2011 Jun;98(6):825-34. doi: 10.1002/bjs.7456. Epub 2011 Apr 11.
PMID: 21484773RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphanie Truant, MD
University Hospital, Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2016
First Posted
April 28, 2016
Study Start
December 8, 2015
Primary Completion
December 10, 2021
Study Completion
December 10, 2021
Last Updated
April 21, 2026
Record last verified: 2025-04