Gastric Intestinal MetaplasiaNCT04348266
RFA for GIM Treatment
A study testing Radiofrequency ablation (RFA) in people with Gastric Intestinal Metaplasia and Treatment, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Intestinal Metaplasia, Treatment, Radio-frequency Ablation
- What is being tested?
- Radiofrequency ablation (RFA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2020to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years of age
- Previous diagnose of extensive or incomplete GIM
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Radiofrequency Ablation in Treatment of Gastric Intestinal Metaplasia: a Randomized, Self-control Study
Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment.
Read the 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.
- Being tested
- Radiofrequency ablation (RFA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| RFA | Experimental | The assigned location will be treated with RFA at all lesion. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of GIM lesions regression
Regression of GIM lesions after RFA treatment compared to no treatment
Measured: 1 year
Secondary outcomes (1)
Number of GIM regression by location
Regression from extensive to non-extensive GIM after RFA treatment compared to no treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jun 2020
- Primary completion28 Feb 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Intestinal MetaplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study in only GIM patients but will divide the stomach into 2 sites (left and right) to random for RFA treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348266
- Sponsor's protocol ID
- RP020
- Status last verified
- Jul 2023
- First submitted
- 12 Apr 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do not share IPD to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radiofrequency Ablation in Treatment of Gastric Intestinal Metaplasia: a Randomized, Self-control Study
- ClinicalTrials.gov ID
- NCT04348266
- Acronym / sponsor ID
- RP020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study in only GIM patients but will divide the stomach into 2 sites (left and right) to random for RFA treatment.
| Arm | Type | Receives |
|---|---|---|
| RFA | Experimental | Device: Radiofrequency ablation (RFA)The assigned location will be treated with RFA at all lesion. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- More than 18 years of age
- Previous diagnose of extensive or incomplete GIM
Key exclusion criteria (6 listed)
- No GIM at first endoscopy
- Previous gastric surgery
- Coagulopathy
- Pregnancy or lactation
- Unable to perform appropriate peri-procedural cessation of antiplatelet/antithrombotic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablation (RFA)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. | Device | RFA |
Primary outcome
Number of GIM lesions regression
Time frame: 1 year
Regression of GIM lesions after RFA treatment compared to no treatment
1 secondary outcome
Number of GIM regression by location
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No. Do not share IPD to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation (RFA) in people with Gastric Intestinal Metaplasia and Treatment, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of GIM lesions regression (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.