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Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

Primary Purpose

Gastric Dysplasia, Intestinal Metaplasia

Status
Completed
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
Endoscopic radiofrequency ablation catheter
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Dysplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoscopic radiofrequency ablation

Arm Description

Endoscopic radiofrequency ablation using BARRX HALO90 catheter

Outcomes

Primary Outcome Measures

Histological clearance of dysplasia/metaplasia

Secondary Outcome Measures

Number of Participants with Adverse Events

Full Information

First Posted
June 4, 2012
Last Updated
December 18, 2013
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01614418
Brief Title
Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
Official Title
Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Dysplasia, Intestinal Metaplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic radiofrequency ablation
Arm Type
Experimental
Arm Description
Endoscopic radiofrequency ablation using BARRX HALO90 catheter
Intervention Type
Device
Intervention Name(s)
Endoscopic radiofrequency ablation catheter
Other Intervention Name(s)
BARRX HALO90
Intervention Description
Endoscopic radiofrequency ablation
Primary Outcome Measure Information:
Title
Histological clearance of dysplasia/metaplasia
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Time Frame
up to 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Keung Leung, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
26897966
Citation
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.
Results Reference
derived

Learn more about this trial

Radiofrequency Ablation for Gastric Metaplasia and Dysplasia

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