Effectiveness of Somatostatin Analogues in patients with Gastric antral vascular ectasia and symptomatic gastrointestinal bleeding: SAGAVE-trial - SAGAVE-trial

Radboud Universitair Medisch Centrum0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all
•of the following criteria:
•- Patients older than 18 years with written informed consent.
•- Endoscopic diagnosis of GAVE, confirmed within the last 12 months
•- 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
•- Substantial transfusion dependency: at least 4 blood units and / or
•intravenous iron (per 500mg) in the 6 months prior to study inclusion with:
•* 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
•* 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 red blood cell
•transfusion above.

•A potential subject who meets any of the following criteria will be excluded
•from participation in this study:
•- Insulinoma
•- Uncontrolled diabetes mellitus as defined by HbA1c >64 mmol/ml, despite
•adequate therapy,
•- Symptomatic cholecystolithiasis (possible side effect octreotide),
•- Pregnancy or nursing women or women have a pregnancy wish during the study
•- Liver cirrhosis Child-Pugh C
•- Chronic or acute pancreatitis
•- Patients with other plausible causes of gastrointestinal bleeding (e.g.
•severe portal hypertensive gastropathy and oesophageal varices which have
•recently bled)
•- Bradycardia (heart rate below 50)*
•- Hypersensitivity to the active ingredient (octreotide) or to auxiliary
•materials of the study medication
•- Severe diseases / comorbidities with a life expectancy < 1 year
•- Use of other anti-angiogenic drug treatment (thalidomide and / or bevacizumab)
•*If a patient has a heart rate below 60 and uses cardiovascular medication that
•affect the heart rate (e.g. beta blockers and calcium channel blockers) the
•prescribing specialist (or another competent specialist) will be consulted
•about the possibility to adjust the dose of these medicines. Patients with a
•heartrate below 50 (despite dose adjustments) will be excluded from
•participation.

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