GAVE - Gastric Antral Vascular Ectasia
Conditions
Keywords
GAVE, RADIOFREQUENCY TREATMENT, BLOOD TRANSFUSION
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.
Interventions
PROCEDUREEndoscopic Radiofrequency treatment
Treatment 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
OTHERQoL EQ5D questionaire
Quality 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
Sponsors
Medtronic
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of sustained increase in Hemoglobin (Hgb) (at least Hgb 10.5 grams/deciliter) | 1 year from enrolling plus six months of follow-up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| patient's need for transfusions and/or infusions of i.v. iron supplementation | 6 and 12 months after the end of RFA treatment | 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 | 1 year from enrolling plus six months of follow-up | 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 | 1 year from enrolling plus six months of follow-up | cost-effectiveness analysis on the effects of Radiofrequency treatment in patients with GAVE. |
Contacts
Primary ContactStefania Marangi, MD
Backup ContactMaurizio Polignano
Outcome results
None listed