The effectiveness of the drug octreotide to anemia in patients with small bowel bleeding due to vascualr malformations.

Conditions: small bowel angiodysplasias
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2014-004032-19-NL

Lead Sponsor: Radboud University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients with refractory anaemia due to gastrointestinal bleeding from small bowel angiodysplasias without any other possible source of bleeding, who are blood transfusion or iron infusion dependent despite endoscopic intervention and oral iron supplementation.
1. Diagnosis of angiodysplasia is made by upper, lower gastrointestinal endoscopy and video capsule or enteroscopy. Single or multiple 2–5 mm flat bright red spots with round uniform or slightly irregular margins, or lesions appearing as raised and reddened areas with a distinctly irregular margin, when larger than 5 mm are seen.
2. Transfusion dependent: at least 2 blood transfusions or iron infusions in the 6 months before inclusion, despite an attempt to supplement iron orally.
3. Failure of endoscopic therapy: at least one attempt with single balloon enteroscopy or dubbel balloon enteroscopy to coagulate the angiodysplasias with APC within the year of diagnosis of symptomatic AD.

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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- age < 45 years
- liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension
- previous unsuccessful treatment with octreotide for the same indication (refractory anaemia due to angiodysplasias)
- current thalidomide treatment which is effective (no blood transfusion dependency)
- patients with chronic renal failure who have a GFR < 30 ml/min
- severe diseases with life expectancy < 1 year
- patients with left ventricular assist devices (LVAD’s)
- Rendu-Osler-Weber
- pregnancy or nursing women
- uncontrolled diabetes as defined by HbA1C >64 mmol/ml, despite adequate therapy
- hereditary hemorrhagic diseases or haematological disorders with active treatment
- patients with a known hypersensitivity to SST analogues or any component of the sandostatin LAR formulations
- symptomatic cholecystolithiasis
- non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment
- systemic cancer currently undergoing chemotherapy or radiation therapy
- refusal to enter the study
- no understanding of Dutch or English