Clinical trial NCT06830317: Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE
Official title: 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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: GAVE - Gastric Antral Vascular Ectasia
Keywords: GAVE, RADIOFREQUENCY TREATMENT, BLOOD TRANSFUSION
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2025-02-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: evaluation of sustained increase in Hemoglobin (Hgb) (at least Hgb 10.5 grams/deciliter)
timeFrame: 1 year from enrolling plus six months of follow-up
Secondary outcomes:
measure: patient's need for transfusions and/or infusions of i.v. iron supplementation
timeFrame: 6 and 12 months after the end of RFA treatment
measure: endoscopic evaluation of GAVE remission
timeFrame: 1 year from enrolling plus six months of follow-up
measure: cost-effectiveness analysis
timeFrame: 1 year from enrolling plus six months of follow-up
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Gastroenterology Saverio De Bellis Research Hospital
name: Antonio Pisani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Gastroenterology Saverio De Bellis Research Hospital
name: Stefania Marangi, MD
role: STUDY_CHAIR
References:
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