Research on the effectiveness of octreotide in Gastric Antral Vascular Ectasia (GAVE)in patients with anemia.

Phase 1

Active, not recruiting

• Conditions: Gastric Antral Vascular Ectasia (also known as watermelon stomach); Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2020-004075-41-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-21
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

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 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 < 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.

The endoscopic appearance of diffuse-pattern GAVE can be similar to portal hypertensive gastropathy (PHG). An important difference is that PHG only occurs in patients with portal hypertension. A patient with portal hypertension and no clear endoscopic distinction between both disorders cannot be included, unless a biopsy has been taken to confirm the diagnosis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified