Assessment of the endoscopic ablation by radiofrequency in antral gastropathy and actinic proctitis in Spain

Radiofrequency endoscopic ablation (RFA) is a technique that destroys the tissue by applying the heat locally. Many different diseases are treated with this technique, including various types of cancer. Since the development of interventional endoscopy devices, RFA has become a standard for the treatment of Barrett's esophagus. Currently, this technology has begun to be used in other diseases of the digestive tract for which its use may be indicated. This is the case of GAVE (Gastric Antral Vascular Ectasia) and actinic proctitis.

GAVE is an uncommon cause of recurrent upper gastrointestinal bleeding and, consequently, of iron deficiency anaemia in affected individuals, often resulting in a long-term dependence on blood transfusion. Individuals suffering from GAVE often suffer from other conditions as well, such as liver cirrhosis or autoimmune diseases. Coagulation with argon plasma (APC) is the current standard of care or both GAVE and actinic proctitis, but despite its ease of use and acceptable costs, It can often produce iatrogenic ulcers, which far from improving can worsen the problem. Thus, RFA is an alternative.

Actinic proctitis is a complication that arises after having received radiotherapy for the treatment of tumours of the pelvic region (rectum, uterus, prostate, bladder or testicles) and consists of an inflammation with formation of superficial neovessels of the rectal mucosa with development posterior, medium and long term, vascular lesions that bleed easily. Recently, RFA has been proposed for the treatment of actinic proctitis in Spain. The technique consists of the ablation of the pathological rectal mucosa that contains the abnormal microvessels with subsequent re-epithelialization. Although the data available in the literature are still scarce, the use of RFA as an endoscopic therapy for the treatment of actinic proctitis has shown certain benefits.

The Covidien-BarrxTM generator (Covidien, Sunnyvale, California), formerly called HALO, is the system used. It is the same system used for the treatment of Barrett's esophagus. HALO ablation catheters deploy radiofrequency energy for diseased tissue within the gastrointestinal tract, producing a uniform and repeatable ablation. They allow the elimination of precancerous and carcinogenic tissues from the gastrointestinal tract and reduce the hemorrhages associated with some diseases.

SESCS has evaluated effectiveness, safety and cost-effectiveness of this system, used for both conditions, but also the economic impact for the Canary Islands Health Service the implementation of RFA may bring.

SESCS has performed a quick systematic review of published scientific articles and other relevant documentation. Also, other agencies’ websites were checked for possible health technology assessment reports or systematic reviews. The meta-search engine Trip Database and the following databases were consulted: DARE and HTA of the Center for Reviews and Dissemination (CRD), Cochrane Library, National Institute for Health and Clinical Excellence (NICE), and the International Network of Evaluation Agencies (INAHTA). Subsequently, in order to identify relevant primary studies were consulted in the following databases: Medline (all), EMBASE, CINAHL, Cochrane Library and NHS Economics Evaluation Database (NHS EED) of the CRD. The search was performed on 20th of July, 2017.

No systematic reviews, HTA reports, cost-effectiveness studies or RCTs which are relevant have been found. Only 9 observational studies, published between 2008 and 2017, have been identified.

Five (5) of nine (9) studies concern patients with actinic proctitis. The remaining study evaluates RFA in a mixed population formed by patients with GAVE and patients with actinic proctitis. The total number of patients among the 9 included studies is 147, of which 82 had GAVE and 65 actinic proctitis.

Conclusions

• The current available evidence for the effectiveness and clinical safety of RFA for the treatment of GAVE comes from 6 uncontrolled observational studies (N = 82) with small sample sizes and with important methodological risks
• The use of RFA for the treatment of GAVE reduces the requirements of blood transfusions, allowing the suspension of transfusions in most cases [very low quality of evidence]
• The current available evidence for the effectiveness and clinical safety of RFA for the treatment of actinic proctitis comes from 4 uncontrolled observational studies (N = 62) with small sample sizes and with important methodological risks
• The use of RFA for the treatment of actinic proctitis reduces the requirements of blood transfusions, allowing the suspension of transfusions in most cases. Likewise, it has a beneficial effect on the symptoms of the disease [very low quality of evidence]
• The RFA procedure is generally safe for the treatment of GAVE and actinic proctitis [very low quality of evidence]
• There are no studies on the cost-effectiveness of RFA in patients with GAVE or actinic proctitis
• The absence of comparative studies of quality prevents estimating the net budgetary impact that would involve using RFA in patients with GAVE or actinic proctitis. The cost of the interventions is estimated at a minimum of € 3,200 per patient

Taking into consideration the conclusions above, the authors do not recommend the use of RFA for GAVE and actinic proctitis. New studies, of higher quality and sample size are required, as well as a cost-effectiveness study.

See the full report in Spanish here.

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