CompletedPhase 4

Radiofrequency Ablation for the Treatment of Gastric Dysplasia

Portugal10 participantsStarted 2011-01

Plain-language summary

The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been studied. The investigators aim to study the efficacy, safety and tolerability of RFA in the treatment of dysplastic gastric mucosa.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histological confirmation of gastric dysplasia.
✓. The lesion is no larger than 5 cm in diameter.
✓. Age ≥ 18 years.
✓. Subject is able to tolerate endoscopy and sedation.
✓. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.

Exclusion criteria

✕. Prior gastric irradiation or surgery.
✕. Anti-platelet or anti-thrombotic medication use that can not be stopped for 7 days before and after RFA.
✕. Gastric ulcers, fistulae, varices and malignancy.
✕. History of alcohol and/or controlled substance dependency.
✕. Pregnancy.

What they're measuring

The % of patients with complete histological clearance of dysplasia.

Timeframe: 12 months

Trial details

NCT IDNCT01523912

SponsorHospital Sao Joao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01

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