Refractory Ascitis Diagnosis by the Study of Labelled Albumin Pharmacokinetics (ARAM)
Refractory Ascitis Diagnosis by the Study of Labelled Albumin Pharmacokinetics Between Peritoneal and Vascular Compartments
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Main objective: assess the performances of PK parameters (transfer of labelled albumin) between peritoneal and vascular compartments, for the diagnosis of refractory ascitis, in patients with cirrhosis and abundant ascitis.
Design: proof of concept study. Interventional cross-sectional study in Beaujon Hospital (Clichy, France), 1 recruiting center and 1 non recruiting center.
Patients are recruited in the Hepatology department (Pr Valla) and PK exploration is performed in the nuclear medicine department (Pr Lebtahi) of Beaujon Hospital.
Description of intervention: diuretics treatment discontinuation 7 days before exploration for patients with sensitive ascitis, and more than 7 days for those with refractory ascitis. The day of exploration, the patients come to hospital and stay in lying position. One intra-veinous injection of 0,015 megabecquerel(MBq) /Kg labelled human serum albumin (Iode-125 (125-I), Séralb®CisBio), in compliance with market authorization, simultaneously to one intra-peritoneal injection of 200 MBq of labelled albumin (Technetium 99m (99m-Tc), Vasculocis®, Cisbio), off-label used. It follows 5 minutes mobilization of the patient (right and left lateral decubitus), then a scintigraphy will be performed using a gamma-camera Symbia T2 (Siemens®). Repeated blood (5 ml) and peritoneal ascitis (3 ml) samples are performed before injection and every 30 minutes for 6 hours (catheter in place). Diuretic treatment can be restarted the day after PK explorations. Patients are followed-up at 1 month by phone call (for the collection of adverse events).
Measurements : radioactivity measurements of 99m-Tc and 125-I in the biological samples are performed by a counter device in the nuclear medicine department (Wizard 3000, Packard®). Unidirectional transfer of labelled albumin (125-I) from vascular compartment (plasma-P) to peritoneal compartment (ascitis-A) (TPA), Unidirectional transfer of labelled albumin (99m-Tc) from peritoneal (A) to vascular compartment (P) (TAP), and the ratio TPA/TAP are calculated from these measurements using Matlab®.The gold standard is defined by the diagnosis of refractory ascitis performed before inclusion.
Statistical analyses: performances of the TAP, of the TPA, and of the ratio TPA/TAP for the diagnosis of refractory ascitis, will be computed using the Receiver Operating Characteristic (ROC) curve.
Number of patients : 30 patients (15 patients with refractory ascitis and 15 patients with sensitive or untreatable ascitis) will be included during a 24 months period (1 or 2 patients per month), and followed-up for 2 months. The PK explorations will be performed in nuclear medicine department not more than 4 weeks after inclusion. Total length of study will be of 26 months.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Clichy, Frankrijk, 92110
- Hôpital Beaujon
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- patients consulting in Hepatology department of Beaujon Hospital
- aged 18 - 80 years old
- cirrhosis due to alcoholic and/or dysmetabolic and/or viral (HBV or HCV) cause, pathologically or clinically/biologically/radiologically proven.
- Volume of ascitis >5 L, either sensible or refractory to diuretics drugs according IAC criteria
Exclusion Criteria:
- infection in the 2 weeks prior to inclusion (suspected or proven)
- upper gastrointestinal bleeding du to portal hypertension in the 2 weeks prior to inclusion
- transjugular intrahepatic portosystemic shunt (TIPS)
- advanced hepatocellular carcinoma
- hepatic transplantation
- unability to stay lying for 6 hours
- pregnancy / lactation
- renal deficiency (creat. clearance < 60ml/min)
- cardiac deficiency (≥ New York Heart Association (NYHA) III) or myocardial infarction (<3 months)
- other cause of ascitis
- contra-indication to human albumin (125-I) or vasculosis (99m-Tc) or other component of radio-pharmaceutics
- no health insurance coverage
- unability to go to the hospital for 1 day of exams
- refuse to consent to study participation
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Ascites in Patients With Cirrhosis
Patients will be further classified according to the refractory or sensitive ascitis
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Intra-veinous injection of 0,015 MBq/Kg ; 0,5 to 2 mL injected over less than a minute
intra-peritoneal injection of 200 MBq of labelled albumin (99m-Tc, Vasculocis®, Cisbio) ; 5 ml injected over less than a minute
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Diagnosis of refractory ascitis according to International Ascites Club (IAC)
Tijdsspanne: Exploration day (4 weeks after the inclusion)
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Exploration day (4 weeks after the inclusion)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Measure of pharmacokinetics parameters : TPA
Tijdsspanne: Exploration day (4 weeks after the inclusion)
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radioactivity measurements of labelled albumin (125-I) in ascitis (peritoneal samples) and plasma (blood samples)
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Exploration day (4 weeks after the inclusion)
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Measure of pharmacokinetics parameters : TAP
Tijdsspanne: Exploration day (4 weeks after the inclusion)
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radioactivity measurements of labelled albumin (99m-Tc) in ascitis (peritoneal samples) and plasma (blood samples)
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Exploration day (4 weeks after the inclusion)
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Measure of pharmacokinetics parameters
Tijdsspanne: Exploration day (4 weeks after the inclusion)
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Ratio TPA/TAP
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Exploration day (4 weeks after the inclusion)
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adverse events
Tijdsspanne: 1 month after exploration day
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Phone call
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1 month after exploration day
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Proportion of patients in whom examination conditions and technical feasibility were completed
Tijdsspanne: Exploration day (4 weeks after the inclusion)
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adequate volume of ascites,stable state of patient, satisfactory spread of radiopharmaceuticals in the peritoneal compartment measure by scintigraphy, number of peritoneal and blood samples performed
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Exploration day (4 weeks after the inclusion)
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: VALLA Dominique, MD, Assistance Publique - Hôpitaux de Paris
Studie record data
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Studie start (Verwacht)
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Studie voltooiing (Verwacht)
Studieregistratiedata
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Eerst geplaatst (Schatting)
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P140902
- 2015-000157-20 (EudraCT-nummer)
Plan Individuele Deelnemersgegevens (IPD)
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