Effectiveness of Somatostatin Analogues in patients with Gastric Antral Vascular Ectasia and symptomatic gastrointestinal bleeding: SAGAVE Pilot study

Radboudumc0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年2月28日

试验速览

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•1) Patients older than 18 years with written informed consent.
•2) Endoscopic diagnosis of GAVE, confirmed within the last 12 months
•3) Endoscopic refractory: at least 1 endoscopic APC, RFA, or other treatment modality performed within 12 months OR unable to receive endoscopic treatment (e.g. Pacemaker, ICD) OR patient has repeatedly indicated that they do not want endoscopic treatment OR treating physician had deemed further endoscopic treatment not relevant
•4) Substantial transfusion dependency: at least 4 blood units and / or intravenous iron in the 6 months prior to study inclusion with:
•a. At least one serum ferritin below < 30 ug/l within the last 6 months requiring iron infusion above or equal to 1 g and/or
•b. Haemoglobin below 5.6 mmol/l (9.0 g/dl) or are in need of transfusions due to anaemia related symptoms within the last 6 months requiring blood transfusion above.

•1) Insulinoma
•2) Uncontrolled diabetes mellitus as defined by HbA1c >64 mmol/ml, despite adequate therapy,
•3) Symptomatic cholecystolithiasis (possible side effect octreotide),
•4) Liver cirrhosis Child-Pugh C
•5) Patients with other plausible causes of gastrointestinal bleeding (e.g. severe portal hypertensive gastropathy and oesophageal varices which have recently bled)
•6) Chronic or acute pancreatitis
•7) Bradycardia (heart rate below 50)*
•8) Hypersensitivity to the active ingredient (octreotide) or to auxiliary materials of the study medication
•9) Severe disease/comorbidities with a life expectancy < 1 year
•10) Pregnancy or nursing women or women who have a pregnancy wish during the study period.
•11) Women of childbearing potential who do not have a confirmed menstrual period and a negative, highly sensitive urine or serum pregnancy test < 7 days before inclusion

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