1) Gastric Antral Vascular Ectasia. 2) Watermelon stomach.
Conditions
Interventions
Octreotide LAR 20mg (Sandostatine) every 4 weeks given during 26 weeks
(treatment period).
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 period. - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute and percentage difference in the mean / median number of intravenous (IV) iron infusions and the mean / median number of red blood cell (RBC) transfusions that was given between the baseline period (26 weeks prior to study inclusion) and the treatment study period (of 26 weeks) and the percentage of patients with a "succesful response", defined as a decrease of >= 50% in the number of IV iron infusions and / or number of RBC transfusions. | — |
Secondary
| Measure | Time frame |
|---|---|
| The absolute mean / median difference and the percentage mean and median difference between the baseline period (26 weeks prior to study inclusion) and the treatment study period (26 weeks) in: - Number of endoscopic treatments - Patient reported outcome measures (PROMS): which include quality of life (measured by the SF-36) and level of fatigue (measured by the multidimensional fatigue inventory (MFI)-20) The absolute mean / median difference and the percentage mean / median difference at baseline ( | — |
Countries
Netherlands
Outcome results
None listed