Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01614418
Recruitment Status : Completed
First Posted : June 8, 2012
Last Update Posted : December 19, 2013
Information provided by (Responsible Party):
LEUNG Wai Keung, 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.

Condition or disease Intervention/treatment Phase
Gastric Dysplasia Intestinal Metaplasia Device: Endoscopic radiofrequency ablation catheter Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
Study Start Date : September 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Endoscopic radiofrequency ablation
Endoscopic radiofrequency ablation using BARRX HALO90 catheter
Device: Endoscopic radiofrequency ablation catheter
Endoscopic radiofrequency ablation
Other Name: BARRX HALO90

Primary Outcome Measures :
  1. Histological clearance of dysplasia/metaplasia [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events [ Time Frame: up to 6 month ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01614418

Hong Kong
University of Hong Kong
Hong Kong, Hong Kong, 0
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Wai Keung Leung, MD The University of Hong Kong

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: LEUNG Wai Keung, Clinical Professor, The University of Hong Kong Identifier: NCT01614418     History of Changes
Other Study ID Numbers: HKU_WKL_RFA1
First Posted: June 8, 2012    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Pathologic Processes