SCINTIVOL: Hepato Biliary Scintigraphy to Assess the Risk of Postoperative Liver Failure Hepatectomies
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
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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.
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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.
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To analyse the inter-centre reproducibility of the hepatobiliary scintigraphy (Central review by the principal investigator of 25 scintigraphy examinations per centre)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Extended hepatectomy Hepatic Scintigraphy |
Device: Hepatobiliary scintigraphy
hepatobiliary scintigraphy with functional assessment of the future remnant liver before an extended hepatectomy of 4 or more segments
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Outcome Measures
Primary Outcome Measures
- Hepatic insufficiency [at 3 months]
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 [at 3 months]
Clavien-Dindo classification
- Duration of intensive care unit stay and of hospitalization [3 months]
Duration of hospitalization
- Histological analysis of the non tumoral liver parenchyma [at 3 months]
correlation of liver parenchymal abnormalities with the results of scintigraphy
- Inter-centre reproducibility of the hepatobiliary scintigraphy [at 3 months]
Central review by the principal investigator of 25 scintigraphy examinations per centre
Eligibility Criteria
Criteria
Inclusion Criteria:
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Noncirrhotic liver
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Benign or malignant liver tumor
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Anatomic hepatic resection ≥ 4 segments
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Aged ≥18
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ASA Score ≤3
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Signed informed consent
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Presence of contraception in non-menopausal women
Exclusion Criteria:
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Cirrhosis
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Absence of preoperative biliary drainage in case of preoperative jaundice
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Patient refusal
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Absence of affiliation to Social Security
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Body weight above 230kg
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Known allergy to Hida derivatives
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Nord, CHU | Amiens | France | ||
| 2 | CHU | Bordeaux | France | ||
| 3 | Hopital Estaing - Chu63 - Clermont Ferrand | Clermont-Ferrand | France | ||
| 4 | CHU | Grenoble | France | ||
| 5 | CHRU, Hôpital Claude Huriez | Lille | France | ||
| 6 | Centre Leon Berard - Lyon 08 | Lyon | France | 69008 | |
| 7 | Hopital Croix-Rousse - Hcl - Lyon 04 | Lyon | France | 69008 | |
| 8 | CHU | Marseille | France | ||
| 9 | Chru Nancy - Hopitaux de Brabois | Nancy | France | ||
| 10 | AP-HPHôpital Beaujon, | Paris | France | ||
| 11 | CHU | Rouen | France | ||
| 12 | CHU | Toulouse | France |
Sponsors and Collaborators
- University Hospital, Lille
- Ministry of Health, France
Investigators
- Principal Investigator: Stéphanie Truant, MD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2014_02
- 2014-A01685-42