Intestinal MetaplasiaNCT04331951
Sensitivity of Targeted Biopsy Within Sydney Protocol for GIM
A study testing Targeted biopsy within Sydney protocol in people with Intestinal Metaplasia, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis Objective: The aim of this study is to evaluate the sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Metaplasia
- What is being tested?
- Targeted biopsy within Sydney protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2019to 31 Oct 2021
- 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
- At least 18 year of age
- Suspected GIM by previous tissue pathology
- Able to provide informed consent for participation
Who cannot join
- Previous gastric surgery including gastrectomy and bypass surgery
- Coagulopathy
- Pregnancy
- Active upper GI bleeding
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, 10330
Rapat Pittayanon, MD
rapat125@gmail.com
About this study
Official title: Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis
Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis
Objective:
The aim of this study is to evaluate the sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis
Research design: Diagnosis study
Sample size: 105 cases
Data analysis:
The outcomes will be presented using 2 by 2 tables and if the data are normal distribution the categorical data will be analysed using McNemar's test
Read the detailed description
Background and Rationale:
Gastric cancer has been in the top-5 of cancer-related death worldwide. Early detection by screening program in high risk patients is very important. If we can detect pre-malignant lesion eg. gastric intestinal metaplasia, we can provide the appropriate surveillance program to those patients. However, the screening protocol for gastric intestinal metaplasia remained unclear. Recently in July 2019, British Society of Gastroenterology published the guideline on the diagnosis and management of patients at risk of gastric adenocarcinoma. The image-enhanced endoscopy (IEE) is recommended as the best modality for assessing gastric intestinal metaplasia. Additionally, they recommended taking biopsy by using Sydney protocol which means taking biopsy at two areas for antrum, two areas for body and one for incisura although they look normal. We aimed to evaluate the sensitivity of this protocol for extensive gastric intestinal metaplasia (GIM) diagnosis in this study.
Methodology:
- All patients with history of GIM will be enrolled and undergone standard with white light esophagogastroduodenoscopy (EGD).
- Those with suspected lesions of GIM will proceed to narrow band imaging (NBI)-mode endoscopy.
- Targeted biopsy will be done at the suspected GIM lesions. Random biopsy will be while will be done if no suspicious GIM lesion seen.
Data collection:
All data will be processed and recorded by one physician.
- Conditions
- Intestinal Metaplasia
- Being tested
- Targeted biopsy within Sydney protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted biopsy within Sydney protocolDiagnostic test
Biopsy at suspicious GIM lesions at any area of antrum (both lesser and greater curvature site), body (both lesser and greater curvature site) and incisura. If there is no abnormal mucosa seen at any site, random biopsy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Targeted biopsy within Sydney Protocol | Experimental | The patients with history of gastric intestinal metaplasia will be included and using targeted biopsy within Sydney Protocol; both targeted biopsy at suspicious lesions and random biopsy at no suspicious area.
* All tissues will be sent to immunohistochemistry as a gold standard.
* Sensitivity, specificity,positive predictive value, negative predictive value, accuracy will be calculated. Receives: Diagnostic Test: Targeted biopsy within Sydney protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis
Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis
Measured: 4 weeks after completing the enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Nov 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
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
- Investigators
- Rapat Pittayanon, MD, Principal investigator, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331951
- Sponsor's protocol ID
- RP016
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis
- ClinicalTrials.gov ID
- NCT04331951
- Acronym / sponsor ID
- RP016
- Conditions
- Intestinal Metaplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 2 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.
Sensitivity of Targeted Biopsy Within Sydney Protocol by Using Narrow Band Imaging for Extensive Gastric Intestinal Metaplasia Diagnosis
Objective:
The aim of this study is to evaluate the sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis
Research design: Diagnosis study
Sample size: 105 cases
Data analysis:
The outcomes will be presented using 2 by 2 tables and if the data are normal distribution the categorical data will be analysed using McNemar's test
Detailed description
Background and Rationale:
Gastric cancer has been in the top-5 of cancer-related death worldwide. Early detection by screening program in high risk patients is very important. If we can detect pre-malignant lesion eg. gastric intestinal metaplasia, we can provide the appropriate surveillance program to those patients. However, the screening protocol for gastric intestinal metaplasia remained unclear. Recently in July 2019, British Society of Gastroenterology published the guideline on the diagnosis and management of patients at risk of gastric adenocarcinoma. The image-enhanced endoscopy (IEE) is recommended as the best modality for assessing gastric intestinal metaplasia. Additionally, they recommended taking biopsy by using Sydney protocol which means taking biopsy at two areas for antrum, two areas for body and one for incisura although they look normal. We aimed to evaluate the sensitivity of this protocol for extensive gastric intestinal metaplasia (GIM) diagnosis in this study.
Methodology:
- All patients with history of GIM will be enrolled and undergone standard with white light esophagogastroduodenoscopy (EGD).
- Those with suspected lesions of GIM will proceed to narrow band imaging (NBI)-mode endoscopy.
- Targeted biopsy will be done at the suspected GIM lesions. Random biopsy will be while will be done if no suspicious GIM lesion seen.
Data collection:
All data will be processed and recorded by one physician.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted biopsy within Sydney Protocol | Experimental | Diagnostic Test: Targeted biopsy within Sydney protocolThe patients with history of gastric intestinal metaplasia will be included and using targeted biopsy within Sydney Protocol; both targeted biopsy at suspicious lesions and random biopsy at no suspicious area. * All tissues will be sent to immunohistochemistry as a gold standard. * Sensitivity, specificity,positive predictive value, negative predictive value, accuracy will be calculated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 year of age
- Suspected GIM by previous tissue pathology
- Able to provide informed consent for participation
Key exclusion criteria (4 listed)
- Previous gastric surgery including gastrectomy and bypass surgery
- Coagulopathy
- Pregnancy
- Active upper GI bleeding
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 |
|---|---|---|
| Targeted biopsy within Sydney protocolBiopsy at suspicious GIM lesions at any area of antrum (both lesser and greater curvature site), body (both lesser and greater curvature site) and incisura. If there is no abnormal mucosa seen at any site, random biopsy will be performed. | Diagnostic test | Targeted biopsy within Sydney Protocol |
Primary outcome
Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis
Time frame: 4 weeks after completing the enrollment.
Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
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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.
Rapat Pittayanon, MD principal investigator
King Chulalongkorn Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted biopsy within Sydney protocol in people with Intestinal Metaplasia, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rapat Pittayanon, MD (66804224999, rapat125@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of targeted biopsy within Sydney protocol by using narrow band imaging for Extensive Gastric Intestinal Metaplasia diagnosis (time frame: 4 weeks after completing the enrollment.). 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 6 Apr 2021.