To assess the efficacy of octreotide in decreasing the need for iron infusions or blood transfusions in patients with refractory gastrointestinal bleedings due to small bowel angiodysplasias despite endoscopic intervention.
ID
Source
Brief title
Condition
- Gastrointestinal haemorrhages NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
* 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 octreotide
compared to the control group
* Mortality and cause of death compared between the control and treatment arm
during the treatment period
Background summary
Gastrointestinal angiodysplasias are an important cause of difficult to manage
bleeding, especially in older patients. Some patients are transfusion dependent
due to rebleedings despite endoscopic intervention. In small cohort studies
octreotide appears to decrease the bleeding episodes in those patients.
Study objective
To assess the efficacy of octreotide in decreasing the need for iron infusions
or blood transfusions in patients with refractory gastrointestinal bleedings
due to small bowel angiodysplasias despite endoscopic intervention.
Study design
Multicenter, randomised, open-label intervention study.
Intervention
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.
Study burden and risks
The burden consist of extra vistis, 3x physical examination and 6x blood
samples, and fill in two questionnaires 3 times. Half of the patients will be
exposed to the somatostatin analogue Sandostatin LAR and thereby are at risk
for the known side-effects. The potential benefit for participating patients is
that Sandostatin may reduce the need for blood transfusions by decreasing the
number of rebleeds in these patients.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
-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)
-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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-004032-19-NL |
| ClinicalTrials.gov | NCT02384122 |
| CCMO | NL50514.091.14 |