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Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

NCT ID: NCT01614418

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Gastric Dysplasia Intestinal Metaplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic radiofrequency ablation

Endoscopic radiofrequency ablation using BARRX HALO90 catheter

Group Type EXPERIMENTAL

Endoscopic radiofrequency ablation catheter

Intervention Type DEVICE

Endoscopic radiofrequency ablation

Interventions

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Endoscopic radiofrequency ablation catheter

Endoscopic radiofrequency ablation

Intervention Type DEVICE

Other Intervention Names

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BARRX HALO90

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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LEUNG Wai Keung

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wai Keung Leung, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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Leung WK, Tong DK, Leung SY, Chan FS, Tong TS, Ho RS, Chu KM, Law SY. Treatment of Gastric Metaplasia or Dysplasia by Endoscopic Radiofrequency Ablation: A Pilot Study. Hepatogastroenterology. 2015 May;62(139):748-51.

Reference Type DERIVED
PMID: 26897966 (View on PubMed)

Other Identifiers

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HKU_WKL_RFA1

Identifier Type: -

Identifier Source: org_study_id