Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Intestinal Metaplasia Clinical Trial

Official title:

Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614418
• Other study ID #: HKU_WKL_RFA1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 4, 2012
• Last updated: December 18, 2013
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Dysplasia
• Intestinal Metaplasia
• Metaplasia

Intervention

Device:
• Endoscopic radiofrequency ablation catheter
Endoscopic radiofrequency ablation

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological clearance of dysplasia/metaplasia		6 month	No
Secondary	Number of Participants with Adverse Events		up to 6 month	Yes