Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEUNG Wai Keung, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01614418
First received: June 4, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Gastric Dysplasia
Intestinal Metaplasia
Device: Endoscopic radiofrequency ablation catheter
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Histological clearance of dysplasia/metaplasia [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: up to 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: September 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endoscopic radiofrequency ablation
Endoscopic radiofrequency ablation using BARRX HALO90 catheter
Device: Endoscopic radiofrequency ablation catheter
Endoscopic radiofrequency ablation
Other Name: BARRX HALO90

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614418

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

No publications provided

Responsible Party: LEUNG Wai Keung, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01614418     History of Changes
Other Study ID Numbers: HKU_WKL_RFA1
Study First Received: June 4, 2012
Last Updated: December 18, 2013
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014