Refractory Ascitis Diagnosis by the Study of Labelled Albumin Pharmacokinetics

NCT02818673 | Unknown Phase 3

• 2 other identifiers: P1409022015-000157-20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Refractory ascites is an indication for liver transplantation, and includes ascites that is resistant to, or intractable by diuretic therapy (International Ascites Club). This definition is partly subjective; it can be established only a posteriori, following diuretic therapy administration to all patients, including those in whom untoward effects are prominent; and requires prolonged follow-up. An early diagnosis of refractory ascites would avoid giving diuretic therapy to patients in whom it will fail and identify rapidly candidates to liver transplantation. Such diagnosis could be done with a pharmacokinetic (PK) study of radiolabeled albumin between the peritoneal cavity and serum.

Conditions

Refractory Ascites in Patients With Cirrhosis

Keywords

diagnostic performances; ascites

Outcome Measures

Primary Outcomes (1)

• Diagnosis of refractory ascitis according to International Ascites Club (IAC)

  Exploration day (4 weeks after the inclusion)

Secondary Outcomes (5)

• Measure of pharmacokinetics parameters : TPA

  Exploration day (4 weeks after the inclusion)

• Measure of pharmacokinetics parameters : TAP

  Exploration day (4 weeks after the inclusion)

• Measure of pharmacokinetics parameters

  Exploration day (4 weeks after the inclusion)

• adverse events

  1 month after exploration day

• Proportion of patients in whom examination conditions and technical feasibility were completed

  Exploration day (4 weeks after the inclusion)

Study Arms (1)

Ascites in Patients With Cirrhosis

EXPERIMENTAL

Patients will be further classified according to the refractory or sensitive ascitis

Radiation: labelled human serumalbumin (125-I, Séralb®CisBio); Radiation: labelled albumin (99m-Tc, Vasculocis®, Cisbio)

Interventions

labelled human serumalbumin (125-I, Séralb®CisBio) RADIATION

Intra-veinous injection of 0,015 MBq/Kg ; 0,5 to 2 mL injected over less than a minute

Ascites in Patients With Cirrhosis

labelled albumin (99m-Tc, Vasculocis®, Cisbio) RADIATION

intra-peritoneal injection of 200 MBq of labelled albumin (99m-Tc, Vasculocis®, Cisbio) ; 5 ml injected over less than a minute

Ascites in Patients With Cirrhosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Beaujon

Clichy, 92110, France

Location

MeSH Terms

Conditions

Ascites

Interventions

Iodine-125

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• VALLA Dominique, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VALLA Dominique, MD

CONTACT

06 09 17 81 28; dominique.valla@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 30, 2016
• Study Start: September 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: June 15, 2017

Record last verified: 2017-06

Locations

FR (1)