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Completed

NCT Number: NCT01614418

Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

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.

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Key information

Conditions

Gastric Dysplasia Intestinal Metaplasia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic radiofrequency ablation catheter

Device

Endoscopic radiofrequency ablation

Other names: BARRX HALO90

Primary outcomes

  1. Histological clearance of dysplasia/metaplasia

    Time frame: 6 month

Secondary outcomes

  1. Number of Participants with Adverse Events

    Time frame: up to 6 month

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 8, 2012
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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