Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Phase 1

Completed

• Conditions: Gastric Dysplasia; Intestinal Metaplasia
• Interventions: Device: Endoscopic radiofrequency ablation catheter

• Registration Number: NCT01614418
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-08
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic radiofrequency ablation	Endoscopic radiofrequency ablation catheter	Endoscopic radiofrequency ablation using BARRX HALO90 catheter

Primary Outcome Measures

Name	Time	Method
Histological clearance of dysplasia/metaplasia	6 month

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	up to 6 month

Trial Locations

Locations (1)

University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong