Nome e qualifica del proponente del progetto: 
sb_p_2509019
Anno: 
2021
Abstract: 

Gastric antral vascular ectasia (GAVE), or "watermelon stomach", is a rare condition that can cause gastrointestinal (GB) bleeding due to the rupture of newly formed blood vessels in the antral gastric mucosa.Medical treatment has not shown satisfactory results and surgery is generally considered a last resort, due to its increased risk of complications and mortality. Argon Plasma Coagulation (APC) has proven to be one of the effective techniques in the treatment of chronic radiation proctitis, and many centers have reported success with this treatment. APC is a thermoablative method that uses a high-frequency current to pass through argon gas to cause thermocoagulation. On the other hands, radiofrequency ablation (RFA) has also shown promise in the treatment of GAVE and actinic proctitis especially in patients who have failed other treatments, such as APC. International studies on the use of RFA for the treatment of GAVE end AP are few, with a low sample size and limited follow-up.The most recent reviews show the need for larger prospective randomized controlled trials in order to understand which endoscopic technique is the most effective in these cases. The aim of this prospective randomized controlled trial study was to examine the comparative efficacy of RFA and APC for the treatment of GAVE, in cirrhotic and non-cirrhotic patients, and AP managed at a single Academic Center. "Naive" patients with confirmed GAVE or AP were recruited to this study and divided into two main groups: GAVEnd (patients with GAVE) and ProctEnd (patients with AP). Each main group will be divided into two subgroups related to treatment with RFA or APC. Patients will be randomly assigned to each group. Randomisation will be carried out using a previously developed randomisation table. The primary outcome will be the efficacy of APC and RFA. Secondary outcomes will include tolerability and feasibility.

ERC: 
LS7_7
LS7_10
LS7_3
Componenti gruppo di ricerca: 
sb_cp_is_3242916
sb_cp_is_3514699
sb_cp_is_3539055
sb_cp_is_3550240
sb_cp_is_3552744
sb_cp_is_3431504
sb_cp_is_3590316
sb_cp_is_3358683
Innovatività: 

Radio frequency ablation (RFA) is a relatively new technique. Born in other clinical fields, the prototypes of the devices used in the upper gastrointestinal tract, took shape with the circumferential model the BarrxTM HALO 360 patented by Ganz et al in 1999. Approved in 2001 by the Food and Drug Administration (FDA) initially for their used only for the treatment of Barrett's esophagus, in 2015, the "family" of focal catheters received approval from the FDA, for their use in other diseases of the gastrointestinal tract. Despite this, even today the use of RFA in digestive endoscopy finds a clear and defined indication only in Barrett's esophagus.
In recent years, there has been an increasing interest in the use of this method in other pathologies of the gastrointestinal tract and the hepato-biliopancreatic district. Among these, certainly the most promising results have been observed in Gastric Antral Vascular Ectasia (GAVE) and actinic proctitis (AP), chronic diseases, where in cases of failure of standard treatment with Argon Plasma Coagulation (APC) or with other endoscopic therapies , the RFA appears to show encouraging data both in terms of efficacy, tolerability and safety.

Codice Bando: 
2509019

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