A Multicenter, Observational, Prospective Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions Compared with Conventional Therapies in Patients with Gastric Antral Vascular Ectasia (GAVE)
| Registry | NCT06830317, acronym GAVE |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 80 (Estimated) |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis (Other); collaborators: Medtronic |
| Conditions | GAVE - Gastric Antral Vascular Ectasia |
| Interventions | Endoscopic Radiofrequency treatment, QoL EQ5D questionaire (Procedure, other) |
| Dates | start 2025-04-02 (estimated), primary completion 2027-07-02 (estimated), completion 2027-09-02 (estimated), first posted 2025-02-17, last updated 2025-02-17 |
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All trials for GAVE - Gastric Antral Vascular Ectasia All trials of Endoscopic Radiofrequency treatment All trials of QoL EQ5D questionaire
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.
In the period from March 2025 to June 2027 n. 80 patients from 21 different medical Centers across Italy will be screened and their endoscopic findings will be shared centrally for the approval and confirmation of the GAVE diagnosis.
Formal written informed consent will take from patients to join the study. The study will be approved by our Ethics Committee of the promoting center (conforming to the 1975 Declaration of Helsinki).
Inclusion and exclusion criteria will be applied until the expected sample size is reached.
Following the GAVE diagnosis confirmation, all consecutive patients will be enrolled in the study and directed to the initial assessment before the treatment procedures. It is estimated that each center will aim to enroll n. 3-5 of pts in the participating centers over the next 24 months.
Treatment with Radiofrequency will carried out with focal Radiofrequency (RFA) with a through the scope (TTS) catheter at 12 J/cm2 to all visible areas of GAVE under conscious sedation or propofol sedation by experienced team of endoscopists and anesthetists. Prior to treatment, 2% N-acetylcysteine as a mucolytic will be applied.
All patients received pantoprazole (40 mg twice daily) and sucralfate (1 g three times per day) post-endoscopy for 4 weeks.
Following RFA procedures, all patients will return for a repeat endoscopy after 6 weeks for follow up post-treatment. In those for whom there will macroscopic GAVE present at this endoscopy, this will treated with Radiofrequency as at the initial therapy.
After 8 weeks following this, patients will return for a follow-up endoscopy during which images will captured of the gastric mucosa and will enter the follow-up phase during which Hb and ongoing transfusion/iron supplement will record at six and 12 months following the first procedure.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| cohort | Procedure: Endoscopic Radiofrequency treatment; Other: QoL EQ5D questionaire | Patients with existing diagnosis of GAVE (validated by an external expert) |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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) * Able to comply with study requirements and understand and sign the informed consent form Exclusion Criteria: * 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 * Blood coagulation deficit: International normalized ratio (INR)>2, Platelets (PLT) <50,000