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
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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-
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Clichy、フランス、92110
- Hôpital Beaujon
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Diagnosis of refractory ascitis according to International Ascites Club (IAC)
時間枠：Exploration day (4 weeks after the inclusion)
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Exploration day (4 weeks after the inclusion)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Measure of pharmacokinetics parameters : TPA
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：VALLA Dominique, MD、Assistance Publique - Hôpitaux de Paris
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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