Refractory Ascitis Diagnosis by the Study of Labelled Albumin Pharmacokinetics Between Peritoneal and Vascular Compartments
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Diagnosis of refractory ascitis according to International Ascites Club (IAC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Diagnosis of refractory ascitis according to International Ascites Club (IAC)
时间窗: Exploration day (4 weeks after the inclusion)
次要结局
- Measure of pharmacokinetics parameters : TPA(Exploration day (4 weeks after the inclusion))
- Proportion of patients in whom examination conditions and technical feasibility were completed(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)
- Measure of pharmacokinetics parameters : TAP(Exploration day (4 weeks after the inclusion))