Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Endoscopic 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
• Другое QoL 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 app

Первичные конечные точки

• evaluation of sustained increase in Hemoglobin (Hgb) (at least Hgb 10.5 grams/deciliter) [Срок оценки: 1 year from enrolling plus six months of follow-up]

Вторичные конечные точки (3)

• patient's need for transfusions and/or infusions of i.v. iron supplementation [Срок оценки: 6 and 12 months after the end of RFA treatment]
• endoscopic evaluation of GAVE remission [Срок оценки: 1 year from enrolling plus six months of follow-up]
• cost-effectiveness analysis [Срок оценки: 1 year from enrolling plus six months of follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• RIDER JA, KLOTZ AP, KIRSNER JB. Gastritis with veno-capillary ectasia as a source of massive gastric hemorrhage. Gastroenterology. 1953 May;24(1):118-23. No abstract available. PMID 13052170
• Jabbari M, Cherry R, Lough JO, Daly DS, Kinnear DG, Goresky CA. Gastric antral vascular ectasia: the watermelon stomach. Gastroenterology. 1984 Nov;87(5):1165-70. PMID 6332757
• Dulai GS, Jensen DM, Kovacs TO, Gralnek IM, Jutabha R. Endoscopic treatment outcomes in watermelon stomach patients with and without portal hypertension. Endoscopy. 2004 Jan;36(1):68-72. doi: 10.1055/s-2004-814112. PMID 14722858
• Suit PF, Petras RE, Bauer TW, Petrini JL Jr. Gastric antral vascular ectasia. A histologic and morphometric study of "the watermelon stomach". Am J Surg Pathol. 1987 Oct;11(10):750-7. PMID 3499091
• Shander A, Cappellini MD, Goodnough LT. Iron overload and toxicity: the hidden risk of multiple blood transfusions. Vox Sang. 2009 Oct;97(3):185-97. doi: 10.1111/j.1423-0410.2009.01207.x. Epub 2009 Aug 3. PMID 19663936
• Fuccio L, Mussetto A, Laterza L, Eusebi LH, Bazzoli F. Diagnosis and management of gastric antral vascular ectasia. World J Gastrointest Endosc. 2013 Jan 16;5(1):6-13. doi: 10.4253/wjge.v5.i1.6. PMID 23330048
• McCarty TR, Rustagi T. Comparative Effectiveness and Safety of Radiofrequency Ablation Versus Argon Plasma Coagulation for Treatment of Gastric Antral Vascular Ectasia: A Systematic Review and Meta-Analysis. J Clin Gastroenterol. 2019 Sep;53(8):599-606. doi: 10.1097/MCG.0000000000001088. PMID 29952856
• Patel A, Patel S, Wickremesinghe PC, Vadada D. Radiofrequency ablation using Barrx(R) for the endoscopic treatment of gastric antral vascular ectasia: a series of three cases and a review of the literature on treatment options. Clin Exp Gastroenterol. 2017 Jul 10;10:113-120. doi: 10.2147/CEG.S80241. eCollection 2017. PMID 28744150

Идентификаторы

NCT: NCT06830317 · GAVE_STUDY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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