Hepatic InsufficiencySCINTIVOLNCT02753517
Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies
A study testing Hepatobiliary scintigraphy in people with Hepatic Insufficiency, run by University Hospital, Lille at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- Hepatobiliary scintigraphy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 12 sitesFrance
- Study dates
- 8 Dec 2015to 10 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Hôpital Nord, CHU
Amiens
CHU
Bordeaux
Hopital Estaing - Chu63 - Clermont Ferrand
Clermont-Ferrand
CHU
Grenoble
CHRU, Hôpital Claude Huriez
Lille
Centre Leon Berard - Lyon 08
Lyon, 69008
Hopital Croix-Rousse - Hcl - Lyon 04
Lyon, 69008
CHU
Marseille
Chru Nancy - Hopitaux de Brabois
Nancy
AP-HPHôpital Beaujon,
Paris
CHU
Rouen
CHU
Toulouse
About this study
Official title: 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
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.
Read the detailed description
The main aim of the study is to determine the predictive value of (99m)Tc-mebrofenin hepatobiliary scintigraphy in assessing the postoperative risk of liver failure within 3 months of extended hepatectomy of 4 or more segments in noncirrhotic liver. The main endpoint is the three-months postoperative liver failure, defined as an increased International Normalized Ratio (INR) and concomitant hyperbilirubinemia (according to the normal limits of the local laboratory) on or after postoperative day 5 according to the international classification of the ISGLS (International Study Group of Liver Surgery) and classified according to its severity in grade A (no change of the patient's clinical management), grade B (deviation from the regular course but without invasive therapy) and grade C (invasive treatment)
Secondary objectives are:
To determine the predictive value of (99m)Tc-mebrofenin hepatobiliary scintigraphy in assessing the risk of postoperative morbi-mortality (according to Clavien-Dindo classification) within 3 months of extended hepatectomy of 4 or more segments in noncirrhotic liver, and the duration of intensive care unit stay and of hospitalization.
- To assess the correlation between the results of the hepatobiliary scintigraphy and the presence of parenchymal abnormalities such as steatosis, fibrosis or chemotherapy-induced injuries (sinusoidal obstruction syndrome, steatohepatitis) at the histological analysis of the non tumoral liver parenchyma.
- To assess the sensitivity of hepatobiliary scintigraphy in jaundiced patients who had a preoperative biliary endoscopic or radiologic drainage, considering the existing competition between mebrofenin and bilirubin on hepatic receptors.
- To analyse the inter-centre reproducibility of the hepatobiliary scintigraphy (Central review by the principal investigator of 25 scintigraphy examinations per centre)
- Conditions
- Hepatic Insufficiency
- Being tested
- Hepatobiliary scintigraphy
- Keywords
- hepatobiliary scintigraphy, extended hepatectomy, volumetry
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatobiliary scintigraphyDevice
hepatobiliary scintigraphy with functional assessment of the future remnant liver before an extended hepatectomy of 4 or more segments
| Study group | Role | What they receive |
|---|---|---|
| Extended hepatectomy | Other | Hepatic Scintigraphy Receives: Device: Hepatobiliary scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic insufficiency
ISGLS criteria : a definition and grading by the International Study Group of Liver Surgery (ISGLS)of the Posthepatectomy liver failure:
Measured: at 3 months
Secondary outcomes (4)
Postoperative morbi-mortality
Clavien-Dindo classification
Measured: at 3 months
Duration of intensive care unit stay and of hospitalization
Duration of hospitalization
Measured: 3 months
Histological analysis of the non tumoral liver parenchyma
correlation of liver parenchymal abnormalities with the results of scintigraphy
Measured: at 3 months
Inter-centre reproducibility of the hepatobiliary scintigraphy
Central review by the principal investigator of 25 scintigraphy examinations per centre
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start8 Dec 2015
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Stéphanie Truant, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753517
- Sponsor's protocol ID
- 2014_02
- Other IDs
- 2014-A01685-42
- Acronym
- SCINTIVOL
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2016
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 22293167de 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.
PubMed 20869070de 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.
PubMed 20395336de 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.
PubMed 21163547de 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.
PubMed 21484773
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02753517
- Acronym / sponsor ID
- SCINTIVOL / 2014_02
- Conditions
- Hepatic Insufficiency
- Keywords
- hepatobiliary scintigraphy, extended hepatectomy, volumetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 8 Dec 2015 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 28 Apr 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.
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.
Detailed description
The main aim of the study is to determine the predictive value of (99m)Tc-mebrofenin hepatobiliary scintigraphy in assessing the postoperative risk of liver failure within 3 months of extended hepatectomy of 4 or more segments in noncirrhotic liver. The main endpoint is the three-months postoperative liver failure, defined as an increased International Normalized Ratio (INR) and concomitant hyperbilirubinemia (according to the normal limits of the local laboratory) on or after postoperative day 5 according to the international classification of the ISGLS (International Study Group of Liver Surgery) and classified according to its severity in grade A (no change of the patient's clinical management), grade B (deviation from the regular course but without invasive therapy) and grade C (invasive treatment)
Secondary objectives are:
To determine the predictive value of (99m)Tc-mebrofenin hepatobiliary scintigraphy in assessing the risk of postoperative morbi-mortality (according to Clavien-Dindo classification) within 3 months of extended hepatectomy of 4 or more segments in noncirrhotic liver, and the duration of intensive care unit stay and of hospitalization.
- To assess the correlation between the results of the hepatobiliary scintigraphy and the presence of parenchymal abnormalities such as steatosis, fibrosis or chemotherapy-induced injuries (sinusoidal obstruction syndrome, steatohepatitis) at the histological analysis of the non tumoral liver parenchyma.
- To assess the sensitivity of hepatobiliary scintigraphy in jaundiced patients who had a preoperative biliary endoscopic or radiologic drainage, considering the existing competition between mebrofenin and bilirubin on hepatic receptors.
- To analyse the inter-centre reproducibility of the hepatobiliary scintigraphy (Central review by the principal investigator of 25 scintigraphy examinations per centre)
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extended hepatectomy | Other | Device: Hepatobiliary scintigraphyHepatic Scintigraphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Noncirrhotic liver
- Benign or malignant liver tumor
- Anatomic hepatic resection ≥ 4 segments
- Aged ≥18
- ASA Score ≤3
Key exclusion criteria (6 listed)
- Cirrhosis
- Absence of preoperative biliary drainage in case of preoperative jaundice
- Patient refusal
- Absence of affiliation to Social Security
- Body weight above 230kg
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 scintigraphyhepatobiliary scintigraphy with functional assessment of the future remnant liver before an extended hepatectomy of 4 or more segments | Device | Extended hepatectomy |
Primary outcome
Hepatic insufficiency
Time frame: at 3 months
ISGLS criteria : a definition and grading by the International Study Group of Liver Surgery (ISGLS)of the Posthepatectomy liver failure:
4 secondary outcomes
Postoperative morbi-mortality
Time frame: at 3 months
Duration of intensive care unit stay and of hospitalization
Time frame: 3 months
Histological analysis of the non tumoral liver parenchyma
Time frame: at 3 months
Inter-centre reproducibility of the hepatobiliary scintigraphy
Time frame: at 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 21 Apr 2026.
- Results publication: PubMed 22293167Bennink 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.
- Results publication: PubMed 20869070de 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.
- Results publication: PubMed 20395336de 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.
- Results publication: PubMed 21163547de 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.
- Results publication: PubMed 21484773de 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.
- Individual participant dataSharing planned: Undecided
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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.
Stéphanie Truant, MD principal investigator
University Hospital, Lille
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatobiliary scintigraphy in people with Hepatic Insufficiency, run by University Hospital, Lille at 12 sites in France.
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 7 inclusion and 6 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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?
Hepatic insufficiency (time frame: at 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 NCT02753517, which also lists 5 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 21 Apr 2026.