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

NCT06830317 | Not Yet Recruiting

• 1 other identifier: GAVE_STUDY
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

GAVE - Gastric Antral Vascular Ectasia

Keywords

GAVE, RADIOFREQUENCY TREATMENT, BLOOD TRANSFUSION

Outcome Measures

Primary Outcomes (1)

• 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

  1 year from enrolling plus six months of follow-up

Secondary Outcomes (3)

• patient's need for transfusions and/or infusions of i.v. iron supplementation

  6 and 12 months after the end of RFA treatment

• endoscopic evaluation of GAVE remission

  1 year from enrolling plus six months of follow-up

• cost-effectiveness analysis

  1 year from enrolling plus six months of follow-up

Study Arms (1)

cohort

Patients with existing diagnosis of GAVE (validated by an external expert)

Procedure: Endoscopic Radiofrequency treatment; Other: QoL EQ5D questionaire

Interventions

Endoscopic Radiofrequency treatment PROCEDURE

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

Also known as: RFA with a TTS catheter at 12 Joule/cm2

cohort

QoL EQ5D questionaire OTHER

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

cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• Able to comply with study requirements and understand and sign the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead
• Medtronic: collaborator

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Magee C, Lipman G, Alzoubaidi D, Everson M, Sweis R, Banks M, Graham D, Gordon C, Lovat L, Murray C, Haidry R. Radiofrequency ablation for patients with refractory symptomatic anaemia secondary to gastric antral vascular ectasia. United European Gastroenterol J. 2019 Mar;7(2):217-224. doi: 10.1177/2050640618814659. Epub 2018 Nov 15.

  PMID: 31080606 BACKGROUND

• Hayashi S, Saeki S. Endoscopic microvascular architecture of the portale hypertensive gastric mucosa on narrow band imaging. Dig Endosc 2007; 19: 116-123.

  BACKGROUND

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Angiodysplasia; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Antonio Pisani, MD

  National Institute of Gastroenterology Saverio De Bellis Research Hospital

  PRINCIPAL INVESTIGATOR

• Stefania Marangi, MD

  National Institute of Gastroenterology Saverio De Bellis Research Hospital

  STUDY CHAIR

Central Study Contacts

Stefania Marangi, MD

CONTACT

0804994233; dott.marangistefania@gmail.com

Maurizio Polignano

CONTACT

0804994365; maurizio.polignano@irccsdebellis.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: April 2, 2025
• Primary Completion (Estimated): July 2, 2027
• Study Completion (Estimated): September 2, 2027
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share