Primary Objective: To investigate the efficacy and safety of octreotide treatment (a somatostatin analogue) in decreasing the transfusion requirements (IV iron infusions and / or red blood cell transfusions) in patients with GI bleeding caused by…
ID
Source
Brief title
Condition
- Gastrointestinal haemorrhages NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The absolute and percentage difference in the mean / median number of
intravenous (IV) iron infusions and the mean / median number of red blood cell
(RBC) transfusions that was given between the baseline period (26 weeks prior
to study inclusion) and the treatment study period (of 26 weeks) and the
percentage of patients with a "succesful response", defined as a decrease of >=
50% in the number of IV iron infusions and / or number of RBC transfusions.
Secondary outcome
The absolute mean / median difference and the percentage mean and median
difference between the baseline period (26 weeks prior to study inclusion) and
the treatment study period (26 weeks) in:
- Number of endoscopic treatments
- Patient reported outcome measures (PROMS): which include quality of life
(measured by the SF-36) and level of fatigue (measured by the multidimensional
fatigue inventory (MFI)-20)
The absolute mean / median difference and the percentage mean / median
difference at baseline (< 7 days before inclusion) between and after 4 weeks,
12 weeks, and 26 weeks of the study period in the value of:
- Hemoglobin and ferritin levels
The absolute number of (S)AE's reported during the treatment study period (of
26 weeks) and the absolute number of patients and percentage of patients that
reported at least one (S)AE.
Background summary
Gastric Antral Vascular Ectasia (GAVE) is an important cause of difficult to
manage bleeding, especially in older patients. There is a lack of effective,
long-term treatment in patients with GAVE. Many patients are therefore
transfusion dependent due to rebleeding despite endoscopic intervention. In
other vascular disorders of the gastrointestinal tract (angiodysplasia and
hereditary hemorrhagic telangiectasia) octreotide appears to decrease bleeding
episodes.
Study objective
Primary Objective: To investigate the efficacy and safety of octreotide
treatment (a somatostatin analogue) in decreasing the transfusion requirements
(IV iron infusions and / or red blood cell transfusions) in patients with GI
bleeding caused by GAVE, who are refractory to endoscopic therapy.
Secondary Objective(s): To investigate the efficacy of octreotide in:
decreasing the endoscopic treatment frequency, increasing the health-related
quality of life and decreasing the level of fatigue.
Study design
Multicenter prospective cohort pilot study (addition of octreotide to the
standard of care) in 12 endoscopic treatment refractory patients, with iron
infusion and / or red blood cell transfusion dependency. The broad inclusion
criteria are applicable to a wide range of GAVE patients with GI bleeding and
the trial is set up to conform clinical practice as much as possible. Three
centers (Radboudumc, Amsterdam UMC, LUMC) will recruit patients for inclusion.
Patients who give informed consent will be treated for 26 weeks with octreotide
+ standard of care. Endoscopic treatments are, on the discretion of the
treating physician, allowed during the trial as part of standard of care.
Follow-up will be at 30 weeks (4 weeks after the last injection).
Intervention
Octreotide LAR 20mg (Sandostatine) every 4 weeks given during 26 weeks
(treatment period).
Study burden and risks
The burden consists of extra visits (4 times), physical examinations (2 times),
blood samples (4 times), and questionnaires (2 times). Patients will also be
exposed to the somatostatin analogue Sandostatin LAR and thereby are at risk
for known side-effects. The potential benefit for participating patients is
that Sandostatin may reduce the need for iron infusions and/or red blood cell
blood transfusions by decreasing the number of rebleeds in these patients.
van 't Santstraat 103
Nijmegen 6523BD
NL
van 't Santstraat 103
Nijmegen 6523BD
NL
Listed location countries
Age
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 (per 500mg) 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.
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.
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 | EUCTR2020-004075-41-NL |
| CCMO | NL75077.091.20 |
| Other | NL8824 |