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

Effectiveness of Somatostatin Analogues in patients with Gastric antral vascular ectasia and symptomatic gastrointestinal bleeding: SAGAVE-Pilot study - SAGAVE-Pilot study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004075-41-NL

Enrollment

Registered

2021-01-21

Start date

2021-02-04

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Antral Vascular Ectasia (also known as watermelon stomach)

Interventions

Trade Name: Sandostatin LAR Product Name: Sandostatin LAR Pharmaceutical Form: Emulsion for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main 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: 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.;Primary end point(s): ‘Successful response’, defined as a decrease of =50% in the number of intravenous iron infusions and / or the number of red blood cell transfusions given between baseline period (26 weeks prior to study inclusion) and during the treatment study period (26 weeks). NB Patients who exclusively or primarily used IV iron infusions at baseline and required (more) red blood cell transfusions during the treatment study period will be counted as treatment failures regardless of their percentual decrease in IV iron infusions. Patients who exclusively or primarily used red blood cell transfusions at baseline and required (more) iron infusions during the treatment study period will be counted as treatment failures if their total number of red blood cell transfusions and iron infusions during the treatment study period exceeds half of the total number of red blood cell transfusions (and iron infusions) during baseline. NB The exact preparation and dosage of IV iron infusions should be noted for each infusion. The preparation of IV iron should be kept consistent at baseline and during study period.;Timepoint(s) of evaluation of this end point: o weeks (study visit 1) 4 weeks (study visit 1) 12 weeks (study visit 2) 26 weeks (study visit 3) 30 weeks (follow-up visit)	—

Measure

Time frame

Main 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: 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.;Primary end point(s): ‘Successful response’, defined as a decrease of =50% in the number of intravenous iron infusions and / or the number of red blood cell transfusions given between baseline period (26 weeks prior to study inclusion) and during the treatment study period (26 weeks). NB Patients who exclusively or primarily used IV iron infusions at baseline and required (more) red blood cell transfusions during the treatment study period will be counted as treatment failures regardless of their percentual decrease in IV iron infusions. Patients who exclusively or primarily used red blood cell transfusions at baseline and required (more) iron infusions during the treatment study period will be counted as treatment failures if their total number of red blood cell transfusions and iron infusions during the treatment study period exceeds half of the total number of red blood cell transfusions (and iron infusions) during baseline. NB The exact preparation and dosage of IV iron infusions should be noted for each infusion. The preparation of IV iron should be kept consistent at baseline and during study period.;Timepoint(s) of evaluation of this end point: o weeks (study visit 1) 4 weeks (study visit 1) 12 weeks (study visit 2) 26 weeks (study visit 3) 30 weeks (follow-up visit)

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Secondary

Measure	Time frame
Secondary end point(s): The absolute mean and/ median difference and the percentage mean and median difference between the half year prior to inclusion baseline (26 weeks prior to study inclusion) and the treatment study period (26 weeks) of patients in the treatment arm compared to patients in the observational arm between the treatment and observational arm in: - Number of red blood cell transfusions - Number of Intravenous iron infusions requirements (per 500mg) - Number of endoscopic treatments The absolute mean and/ median difference and the percentage mean and median difference at baseline (< 7 days before inclusion) between and after 4 weeks, 12 weeks, and 26 weeks of the study period after a half year between patients in the treatment arm and patients in the observational arm in the value of: - Hemoglobin and ferritin levels The absolute mean and/ median difference and the percentage or mean and median difference between baseline (26 weeks prior to study inclusion) and the treatment study period (26 weeks) the value at baseline and after a half year between of patients in the treatment arm compared to patients in the and observational arm in: - 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 or mean and/ median difference and the percentage mean and median difference after a half year in the number of (S)AE’s during the treatment study period (26 weeks) between patients in the treatment arm and patients in the observational arm. The absolute mean and median difference and the percentual mean and median difference between baseline (26 weeks prior to study inclusion) and the treatment study period (26 weeks) of patients in the treatment arm compared to patients in the observational arm in cost effectiveness. Cost effectiveness will be defined by measuring the healthcare costs. The following volumes of hea	—

Measure

Time frame

Secondary end point(s): The absolute mean and/ median difference and the percentage mean and median difference between the half year prior to inclusion baseline (26 weeks prior to study inclusion) and the treatment study period (26 weeks) of patients in the treatment arm compared to patients in the observational arm between the treatment and observational arm in: - Number of red blood cell transfusions - Number of Intravenous iron infusions requirements (per 500mg) - Number of endoscopic treatments The absolute mean and/ median difference and the percentage mean and median difference at baseline (< 7 days before inclusion) between and after 4 weeks, 12 weeks, and 26 weeks of the study period after a half year between patients in the treatment arm and patients in the observational arm in the value of: - Hemoglobin and ferritin levels The absolute mean and/ median difference and the percentage or mean and median difference between baseline (26 weeks prior to study inclusion) and the treatment study period (26 weeks) the value at baseline and after a half year between of patients in the treatment arm compared to patients in the and observational arm in: - 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 or mean and/ median difference and the percentage mean and median difference after a half year in the number of (S)AE’s during the treatment study period (26 weeks) between patients in the treatment arm and patients in the observational arm. The absolute mean and median difference and the percentual mean and median difference between baseline (26 weeks prior to study inclusion) and the treatment study period (26 weeks) of patients in the treatment arm compared to patients in the observational arm in cost effectiveness. Cost effectiveness will be defined by measuring the healthcare costs. The following volumes of hea

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Countries

Netherlands

Contacts

Public ContactAfdeling MDL

Radboudumc

+310243611111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026