Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies (SCINTIVOL)
Primary Purpose
Hepatic Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hepatobiliary scintigraphy
Sponsored by
About this trial
This is an interventional screening trial for Hepatic Insufficiency focused on measuring hepatobiliary scintigraphy, extended hepatectomy, volumetry
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hôpital Nord, CHURecruiting
- CHURecruiting
- Hopital Estaing - Chu63 - Clermont FerrandRecruiting
- CHURecruiting
- CHRU, Hôpital Claude HuriezRecruiting
- Centre Leon Berard - Lyon 08Recruiting
- Hopital Croix-Rousse - Hcl - Lyon 04Recruiting
- CHURecruiting
- Chru Nancy - Hopitaux de BraboisRecruiting
- AP-HPHôpital Beaujon,Recruiting
- CHURecruiting
- CHURecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Extended hepatectomy
Arm Description
Hepatic Scintigraphy
Outcomes
Primary Outcome Measures
Hepatic insufficiency
ISGLS criteria : a definition and grading by the International Study Group of Liver Surgery (ISGLS)of the Posthepatectomy liver failure:
Secondary Outcome Measures
Postoperative morbi-mortality
Clavien-Dindo classification
Duration of intensive care unit stay and of hospitalization
Duration of hospitalization
Histological analysis of the non tumoral liver parenchyma
correlation of liver parenchymal abnormalities with the results of scintigraphy
Inter-centre reproducibility of the hepatobiliary scintigraphy
Central review by the principal investigator of 25 scintigraphy examinations per centre
Full Information
NCT ID
NCT02753517
First Posted
April 25, 2016
Last Updated
November 18, 2020
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT02753517
Brief Title
Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies
Acronym
SCINTIVOL
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2015 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Insufficiency
Keywords
hepatobiliary scintigraphy, extended hepatectomy, volumetry
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extended hepatectomy
Arm Type
Other
Arm Description
Hepatic Scintigraphy
Intervention Type
Device
Intervention Name(s)
Hepatobiliary scintigraphy
Intervention Description
hepatobiliary scintigraphy with functional assessment of the future remnant liver before an extended hepatectomy of 4 or more segments
Primary Outcome Measure Information:
Title
Hepatic insufficiency
Description
ISGLS criteria : a definition and grading by the International Study Group of Liver Surgery (ISGLS)of the Posthepatectomy liver failure:
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Postoperative morbi-mortality
Description
Clavien-Dindo classification
Time Frame
at 3 months
Title
Duration of intensive care unit stay and of hospitalization
Description
Duration of hospitalization
Time Frame
3 months
Title
Histological analysis of the non tumoral liver parenchyma
Description
correlation of liver parenchymal abnormalities with the results of scintigraphy
Time Frame
at 3 months
Title
Inter-centre reproducibility of the hepatobiliary scintigraphy
Description
Central review by the principal investigator of 25 scintigraphy examinations per centre
Time Frame
at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Truant, MD
Email
stephanie.truant@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie Truant, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Nord, CHU
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc REGIMBEAU, MD
Facility Name
CHU
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence CHICHE, MD
Facility Name
Hopital Estaing - Chu63 - Clermont Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Name
CHU
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian LETOUBLON, MD
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie Truant, MD
Facility Name
Centre Leon Berard - Lyon 08
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Croix-Rousse - Hcl - Lyon 04
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Name
CHU
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean HARDWIGSEN, MD
Facility Name
Chru Nancy - Hopitaux de Brabois
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HPHôpital Beaujon,
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier FARGES, MD
Facility Name
CHU
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilian SCHWARZ Lilian, MD
Facility Name
CHU
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice MUSCARI, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22293167
Citation
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.
Results Reference
result
PubMed Identifier
20869070
Citation
de 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 Reference
result
PubMed Identifier
20395336
Citation
de 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 Reference
result
PubMed Identifier
21163547
Citation
de 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 Reference
result
PubMed Identifier
21484773
Citation
de 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.
Results Reference
result
Learn more about this trial
Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies
We'll reach out to this number within 24 hrs