Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

The University of Hong Kong (HKU)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Intestinal Metaplasia

Gastric Dysplasia

Treatments

Device: Endoscopic radiofrequency ablation catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT01614418

HKU_WKL_RFA1

Details and patient eligibility

About

Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic surveillance, there is no other intervention which predictably eradicates pre-cancerous gastric lesions.

Endoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly effective in eradicating both IM and dysplasia in patients with Barrett's esophagus. However, the potential role of RFA to remove gastric IM and dysplasia remains unknown. In this study, we determine the feasibility of using endoscopic RFA in treating early gastric neoplasia (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will be treated with endoscopic RFA. The safety and effects of RFA will be determined.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histological confirmation of gastric IM or dysplasia.
The lesion is no larger than 5 cm in diameter.
Age ≥ 18 years.
No previous endoscopic mucosal resection or submucosal dissection.
No active H. pylori infection.
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

Gastric cancer (intra-mucosal cancer or worse).
Prior gastric irradiation or surgery.
Anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days before and after RFA.
Gastric ulcers, fistulae and varices.
History of alcohol and/or controlled substance dependency.
Pregnancy.