The aim of the study therefore is to permanently resolve the existence of the bleeding sites caused by Gave and reduce both bleeding episodes and the need for transfusion in such patients applying "Barrx" (trademark) radiofrequency endoscopic ablation technology in selected cohort of patients that will be defined the patient inclusion section.
At least 18 years of age
Existing diagnosis of GAVE (validated by an external expert)
Melena and/or hematemesis secondary to GAVE and/or iron deficiency anemia persisting despite systemic iron therapy or oral supplementation and/or (concentrated red globules) GRC transfusions for at least 6 months
Negative colonoscopy (performed within 12 months prior to enrollment, exclusion of any site of bleeding)
Alternative causes for iron deficiency anemia (gastro-duodenal erosions and/or ulcerations, celiac disease, Inflammatory Bowel Disease (IBD), etc)
Pregnancy
Active malignancy (malignancy diagnosed in past five years or ongoing treatment)
Anatomical malformations precluding treatment with RFA
Participants will have demonstrated inadequate response or intolerance to existing standard-of-care treatments, such as argon plasma coagulation (APC), proton pump inhibitors (PPIs), or somatostatin analogs. This ensures the study evaluates the novel therapy in a population where current interventions have limitations. Patients who have not yet received any treatment for GAVE will also be eligible to assess the efficacy of the new therapy as a first-line option
Cohort
Prospective
Endoscopic Radiofrequency treatment
Procedure/SurgeryTreatment with RFA will carried out with focal RFA with a TTS catheter at 12 Joule/cm2 to all visible areas of GAVE under conscious sedation or propofol sedation by experienced team of endoscopists and anesthetists
QoL EQ5D questionaire
Other interventionQuality of Life EQ5D (by EuroQol Group) before every RFA treatment and at Follow up visits (3, 6 and 12 months after the first procedure). QoL questionnaire EQ5D The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state
evaluation of sustained increase in Hemoglobin (Hgb) (at least Hgb 10.5 grams/deciliter)
compare the number of transfusions per patient pre and post treatment with the evaluation of sustained increase in Hgb (at least Hgb 10.5 g/dl) per patient six months after at least two sequential RFA treatments
patient's need for transfusions and/or infusions of i.v. iron supplementation
evaluate the percentage of patients who achieve the goal of reducing the need for transfusion (respect of patient's clinical history) and/or infusions of i.v. iron supplementation.
endoscopic evaluation of GAVE remission
evaluate endoscopic partial or total regression of areas of GAVE after Radiofrequency treatment (by asking expert endoscopist to estimate the overall percentage change in GAVE).
cost-effectiveness analysis
cost-effectiveness analysis on the effects of Radiofrequency treatment in patients with GAVE.
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Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Lead sponsor
Medtronic
Collaborator
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