Gastric Intestinal MetaplasiaNCT01491724
The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia (GIM)
An observational study of Gastric Intestinal Metaplasia, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) images interpretation in Gastric Intestinal Metaplasia (GIM) Objective: The aim of this study is to evaluate the learning curve of pCLE images interpretation in GIM. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Intestinal Metaplasia
- How many people
- 5 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2011to Apr 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 5 beginner endoscopists who never had the experience in pCLE
Who may be able to join
- First year fellow of gastroenterologist who never have the experienced in pCLE interpretation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Rapat Pittayanon
Bangkok, Bangkok, 10330
Rapat Pittayanon, MD, 66813132112, rapat125@gmail.com
Nuttapaht Namjud, M.Sc, 66894971957, ampere_nut@hotmail.com
About this study
Official title: The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia(GIM)
The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) images interpretation in Gastric Intestinal Metaplasia (GIM)
Objective:
The aim of this study is to evaluate the learning curve of pCLE images interpretation in GIM.
Research design:
Blinded review of pCLE images for the diagnosis of GIM
Sample size:
Five beginner endoscopists will be assigned in this study to read approximately 80 videoclips
Data analysis:
ROC curve is analyzed by SPSS version 16.
Expected Benefit and Clinical Application Information on the learning curve for GIM interpretation from pCLE images in order to develop early gastric cancer detection
Read the detailed description
Background and Rationale:
Gastric cancer remains the second leading cause of cancer related death in the world. The incidence and mortality rate is predominant in East Asia[1]. Usually, gastric cancer is asymptomatic in early stage; therefore, most patients are in the advanced stage and incurable at diagnosis. The pathogenesis of intestinal type gastric cancer is sequential and multistep pathway. Gastric intestinal metaplasia (GIM) is the precancerous lesion for intestinal type gastric cancer[2]. The strategies which can detect precancerous and/or early cancerous transformation are very beneficial because only early gastric cancer can potentially be cured by endoscopic treatment. Probe-based confocal laser endomicroscope or pCLE is useful for GIM detection with 94% in sensitivity[3]. However, this perfect sensitivity in pCLE interpretation is provided in only expertise. We still do not know how to be an expert in GIM interpretation. No study about learning curve in GIM interpretation by pCLE published
Observation and Measurement:
Collect the accuracy in GIM interpretation from pCLE reported in ROC curve
Methodology:
- Six inexperienced pCLE readers were recruited.
- All inexperienced pCLE readers must attend the learning session.
- Self-review from CD is recommended for all inexperienced pCLE readers
- Two-week interval for examination in GIM interpretation from 20 new histology-proved pCLE images (GIM and normal mucosa) for 5 sessions are on schedule after training session.
- All Inexperienced pCLE readers need to review the training CD at least a day before each examination.
- The accuracy rate in each examination will be recorded individually for each inexperienced pCLE reader.
- ROC curve is reported for learning curve in GIM interpretation from pCLE images.
Data collection:
All data will be processed and recorded by one physician.
- Conditions
- Gastric Intestinal Metaplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pCLE images | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of accuracy of pCLE images interpretation in GIM after each examination
Percentage of accuracy changing in each examination
Measured: Baseline and every 2 weeks for 4 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012 (estimated)
- Study completionApr 2012 (estimated)
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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
- Investigators
- Rungsun Rerknimitr, Professor, Study director, King Chulalongkorn Memorial HospitalRapat Pittayanon, MD, Principal investigator, King Chulalongkron Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491724
- Sponsor's protocol ID
- RP001
- Status last verified
- Dec 2011
- First submitted
- 5 Dec 2011
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) Images Interpretation in Gastric Intestinal Metaplasia(GIM)
- ClinicalTrials.gov ID
- NCT01491724
- Acronym / sponsor ID
- RP001
- Conditions
- Gastric Intestinal Metaplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 14 Dec 2011 (estimated)
- 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.
The Learning Curve of Probe-based Confocal Laser Endomicroscopy (pCLE) images interpretation in Gastric Intestinal Metaplasia (GIM)
Objective:
The aim of this study is to evaluate the learning curve of pCLE images interpretation in GIM.
Research design:
Blinded review of pCLE images for the diagnosis of GIM
Sample size:
Five beginner endoscopists will be assigned in this study to read approximately 80 videoclips
Data analysis:
ROC curve is analyzed by SPSS version 16.
Expected Benefit and Clinical Application Information on the learning curve for GIM interpretation from pCLE images in order to develop early gastric cancer detection
Detailed description
Background and Rationale:
Gastric cancer remains the second leading cause of cancer related death in the world. The incidence and mortality rate is predominant in East Asia[1]. Usually, gastric cancer is asymptomatic in early stage; therefore, most patients are in the advanced stage and incurable at diagnosis. The pathogenesis of intestinal type gastric cancer is sequential and multistep pathway. Gastric intestinal metaplasia (GIM) is the precancerous lesion for intestinal type gastric cancer[2]. The strategies which can detect precancerous and/or early cancerous transformation are very beneficial because only early gastric cancer can potentially be cured by endoscopic treatment. Probe-based confocal laser endomicroscope or pCLE is useful for GIM detection with 94% in sensitivity[3]. However, this perfect sensitivity in pCLE interpretation is provided in only expertise. We still do not know how to be an expert in GIM interpretation. No study about learning curve in GIM interpretation by pCLE published
Observation and Measurement:
Collect the accuracy in GIM interpretation from pCLE reported in ROC curve
Methodology:
- Six inexperienced pCLE readers were recruited.
- All inexperienced pCLE readers must attend the learning session.
- Self-review from CD is recommended for all inexperienced pCLE readers
- Two-week interval for examination in GIM interpretation from 20 new histology-proved pCLE images (GIM and normal mucosa) for 5 sessions are on schedule after training session.
- All Inexperienced pCLE readers need to review the training CD at least a day before each examination.
- The accuracy rate in each examination will be recorded individually for each inexperienced pCLE reader.
- ROC curve is reported for learning curve in GIM interpretation from pCLE images.
Data collection:
All data will be processed and recorded by one physician.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pCLE images | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 5 beginner endoscopists who never had the experience in pCLE
Key inclusion criteria (1 listed)
- First year fellow of gastroenterologist who never have the experienced in pCLE interpretation.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change of accuracy of pCLE images interpretation in GIM after each examination
Time frame: Baseline and every 2 weeks for 4 sessions
Percentage of accuracy changing in each examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
- Related InfoLink provided by the sponsor.
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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.
Rungsun Rerknimitr, Professor study director
King Chulalongkorn Memorial Hospital
Rapat Pittayanon, MD principal investigator
King Chulalongkron Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric 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 1 inclusion and 0 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 15 Dec 2011. 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 (66813132112, Rapat125@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of accuracy of pCLE images interpretation in GIM after each examination (time frame: Baseline and every 2 weeks for 4 sessions). 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 15 Dec 2011.