Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01614418

Enrollment

Registered

2012-06-08

Start date

2011-09-30

Completion date

2013-12-31

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Dysplasia, Intestinal Metaplasia

Brief summary

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.

Interventions

DEVICEEndoscopic radiofrequency ablation catheter

Endoscopic radiofrequency ablation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histological confirmation of gastric IM or dysplasia. 2. The lesion is no larger than 5 cm in diameter. 3. Age ≥ 18 years. 4. No previous endoscopic mucosal resection or submucosal dissection. 5. No active H. pylori infection. 6. Subject is able to tolerate endoscopy and sedation. 7. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.

Exclusion criteria

1. Gastric cancer (intra-mucosal cancer or worse). 2. Prior gastric irradiation or surgery. 3. Anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days before and after RFA. 4. Gastric ulcers, fistulae and varices. 5. History of alcohol and/or controlled substance dependency. 6. Pregnancy.

Design outcomes

Primary

Measure	Time frame
Histological clearance of dysplasia/metaplasia	6 month

Secondary

Measure	Time frame
Number of Participants with Adverse Events	up to 6 month

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026