Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 19, 2013
December 1, 2013
2.3 years
June 4, 2012
December 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Histological clearance of dysplasia/metaplasia
6 month
Secondary Outcomes (1)
Number of Participants with Adverse Events
up to 6 month
Study Arms (1)
Endoscopic radiofrequency ablation
EXPERIMENTALEndoscopic radiofrequency ablation using BARRX HALO90 catheter
Interventions
Endoscopic radiofrequency ablation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Hong Kong
Hong Kong, 0, Hong Kong
Related Publications (1)
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.
PMID: 26897966DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Wai Keung Leung, MD
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 8, 2012
Study Start
September 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
December 19, 2013
Record last verified: 2013-12