Effectiveness of Somatostatin Analogues in patients with Gastric Antral Vascular Ectasia and symptomatic gastrointestinal bleeding: SAGAVE Pilot study
- Conditions
- Gastric Antral Vascular Ectasia (GAVE)
- Registration Number
- NL-OMON21472
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameter is a ‘successful response’, defined as a decrease of =50% in the number of red blood cell transfusion units and/or intravenous iron infusion units given during the baseline period (26 weeks prior to study inclusion) and during the treatment study period (26 weeks).
- Secondary Outcome Measures
Name Time Method Important secondary outcome measures are the difference in haemoglobin and ferritin levels between baseline and during the treatment study period and difference in quality of life and level of fatigue (measured by the SF-36 and MFI-20 questionnaires).