RFA for GIM Treatment | NCT04348266

Studies
RFA for GIM Treatment

NCT04348266

Sponsor

King Chulalongkorn Memorial Hospital

Status

Completed

Last Update Posted

Aug 1, 2023Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Gastric Intestinal Metaplasia
Treatment
Radio-frequency Ablation

Interventions

Radiofrequency ablation (RFA)

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Feb 28, 2023Actual

Completion Date

May 31, 2023Actual

First Submitted Date

Apr 12, 2020

First Submission Date that Met QC Criteria

Apr 14, 2020

First Posted Date

Apr 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2023

Last Update Posted Date

Aug 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rapat Pittayanon, Principle investigator, King Chulalongkorn Memorial HospitalPrincipal Investigator

Lead Sponsor

King Chulalongkorn Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment.

Detailed Description

Gastric intestinal metaplasia (GIM) is a pre-malignant lesion. Currently, there is no standard treatment for this condition, thus the patients with GIM need surveillance endoscopy every 1-3 years, regarding to the severity and extension of lesion. However, the protocol for GIM surveillance is uncertain and need high cost.

Radiofrequency ablation (RFA) is used for Barrett's esophagus (BE; pre-malignant lesion of esophageal adenoCA) treatment as a standard treatment. The investigators hypothesized that RFA may effective in GIM treatment.

The investigators will random GIM participants to have the RFA treatment only one site of the stomach (left or right). At the first session, the investigators will biopsy at suspected GIM lesions to confirm the diagnosis and severity of GIM. Two months later, The investigators will apply RFA to all GIM lesions at the assigned location and then every 2 months for 3 sessions or until no GIM lesion seen by endoscopy. The final endoscopy will be done at 1 year follow-up and biopsy will be performed to assess the efficacy of RFA compare to no treatment.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RFA	Experimental	The assigned location will be treated with RFA at all lesion.	Device: Radiofrequency ablation (RFA)
Control	No Intervention	No treatment will not be performed at this location. However, if endoscopist detects any suspicious lesion during the scheduled endoscopy, the biopsy will be done and standard treatment will be performed accordingly.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency ablation (RFA)	Device	Radiofrequency ablation is a device that can generate the heat from radiofrequency for tissue ablation. RFA is a standard treatment for Barrett' esophagus and high grade dysplasia in esophagus.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of GIM lesions regression	Regression of GIM lesions after RFA treatment compared to no treatment	1 year

Secondary Outcomes

Measure	Description	Time Frame
Number of GIM regression by location	Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

More than 18 years of age
Previous diagnose of extensive or incomplete GIM

Exclusion Criteria:

No GIM at first endoscopy
Previous gastric surgery
Coagulopathy
Pregnancy or lactation
Unable to perform appropriate peri-procedural cessation of antiplatelet/antithrombotic therapy
Unable to sign the consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rapat Pittayanon		Pathum Wan	Bangkok	10330	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Do not share IPD to other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

The endoscopist who do the final endoscopy for assessing the efficacy of RFA will be blinded to the previous assigned location of RFA treatment.

Who Masked

Outcomes Assessor