angiodysplasia vascular malformation
Conditions
Interventions
The intervention group receives 40 mg Sandostatin LAR once every four weeks for
52 weeks. The control group receives standard of care for 52 weeks.
Sponsors
Maag-, darm- en leverziekten
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with refractory anaemia due to gastrointestinal bleeding from 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, 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 4 blood transfusions or iron infusions in the year 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.
Exclusion criteria
Exclusion criteria: -age 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| * Percentage of hemoglobin increase from baseline until end of treatment for patients treated with octreotide compared to the control group * The mean difference in hemoglobin level from baseline until end of treatment for patients treated with octreotide compared to the control group * Number of patients requiring red blood cell transfusions from baseline until end of treatment for patients treated with octreotide compared to the control group * Number of patients requiring other transfusions or medication to correct coagulation between baseline until end of treatment for patients treated with octreotide compared to the control group (see *standard of care*) * The change in number and severity of bleeding episodes (see for definition section 4.3.2) between start and end of treatment for patients treated with octreotide compared to the control group * The change in number of patients free of rebleeding between start and end of treatment for patients treated with octreotide compared to the control group * Reduction in oral iron requirement between start and end of treatment for patients treated with octreotide compared to the control group (see for definition section 4.3.3 *standard of care*) * The change in level of serum ferritin between baseline until end of treatment for patients treated with octreotide compared to the control group * The number and type of adverse events (cardiac, pulmonary, neurological, other) between the control and treatment arm during the treatment period F(1) * Difference in number of hospitalizations, ICU admissions and duration of hospitalization between the control and treatment arm during the treatment period F(1) * The need for rescue therapy using argon plasma coagulation, coiling or surgery compared between the control and treatment arm during the treatment period F(1) * Change in Quality of Life as measured by SF36 and PSQ-An questionnaire between baseline and end of treatment for patients treated with | — |
Primary
| Measure | Time frame |
|---|---|
| The percentual decrease in blood and iron requirements between the year prior to inclusion and the treatment period of one year. Percentual decrease = (number of blood transfusions and iron infusions in the year prior to inclusion - number of blood transfusions and iron infusions during the study period ) / number of blood and iron infusions in the year prior to inclusion. The percentual decrease will be compared between the intervention and control arm. All blood transfusions that are given with another indication than gastrointestinal blood loss are registered, but excluded for analysis for the primary outcome. | — |
Countries
Netherlands
Outcome results
None listed