NeoplasmNCT02044536
Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy
An observational study of Neoplasm, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The optimal number of biopsy and the detection rate of neoplastic lesions are not established. The aim of this study is to assess the current practice pattern and effect of training in upper endoscopic biopsy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasm
- How many people
- 1,208 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Jan 2014
- 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: From May to July 2013, all the biopsy specimens from diagnostic esophagogastroduodenoscopy will be collected and analyzed in a single teaching hospital of Korea.
Who may be able to join
- Diagnostic EGD including screening endoscopy for health check-up or endoscopic examinations for the symptomatic patients to make a diagnosis.
Who cannot join
- Specimens from therapeutic procedures, such as endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine
Chuncheon, Gangwon-do, 200-704
About this study
Official title: Retrospective Study of Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy
The optimal number of biopsy and the detection rate of neoplastic lesions are not established. The aim of this study is to assess the current practice pattern and effect of training in upper endoscopic biopsy.
Read the detailed description
The endoscopic examination is indicated in the diagnosis of variety of gastrointestinal diseases and screening for the neoplastic lesions. Especially, in Korea where the stomach cancer prevalent area, high-quality endoscopic examination is required not to overlook pathologic lesions. Endoscopic biopsy is the gold standard for the confirmation of endoscopic diagnosis. It is usually decided based on the abnormal morphology of the lesions or color change of the mucosa. Diagnostic accuracy is known to be improved by training or using optical techniques or chromoendoscopy. With the development of endoscopic imaging technologies such as narrow band imaging (NBI), confocal imaging or magnifying techniques, the diagnostic accuracy can be enhanced. However, inspection with conventional white light endoscopy is still the most prevalent and basic form of screening or surveillance endoscopy. Thus, detecting lesions by meticulous inspection and accurate approach by targeted biopsy are important for the diagnosis of pathologic lesions. However, the optimal number of biopsy and the detection rate of neoplastic lesions are not established. This study aimed at evaluating the current practice pattern and effect of training in conventional upper endoscopic biopsy.
- Conditions
- Neoplasm
- Being tested
- No intervention
- Keywords
- biopsy, endoscopy, neoplasms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
retrospective data review
| Study group | Role | What they receive |
|---|---|---|
| Faculty doctors | Experienced endoscopists (> 6000 cases). no intervention Receives: Other: No intervention | |
| Trainees | Doctors on fellowship who are inexperienced endoscopists (< 4 months of endoscopy training) no intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance rate of endoscopic diagnosis and histologic diagnosis
In the evaluation of concordance rate and discrepancy rate, endoscopic diagnosis in the procedure report and histologic diagnosis in the pathology report will be compared.
Measured: During 3 months (retrospective endoscopy data review)
Secondary outcomes (1)
Neoplastic lesion detection rate
Neoplasm detection rates of diagnostic upper endoscopic biopsy between trainees and faculty doctors will be compared statistically.
Measured: During 3 months (retrospetive endoscopy data review)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Seok Bang, Chuncheon Sacred Heart Hospital
- Investigators
- Chang Seok Bang, MD, Principal investigator, Department of Internal Medicine, Hallym University College of Medicine, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044536
- Sponsor's protocol ID
- BCS-2
- Status last verified
- Oct 2018
- First submitted
- 22 Jan 2014
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Current Practice Pattern and Effect of Training in Upper Endoscopic Biopsy
- ClinicalTrials.gov ID
- NCT02044536
- Acronym / sponsor ID
- BCS-2
- Conditions
- Neoplasm
- Keywords
- biopsy, endoscopy, neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,208 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Jan 2014 (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 optimal number of biopsy and the detection rate of neoplastic lesions are not established. The aim of this study is to assess the current practice pattern and effect of training in upper endoscopic biopsy.
Detailed description
The endoscopic examination is indicated in the diagnosis of variety of gastrointestinal diseases and screening for the neoplastic lesions. Especially, in Korea where the stomach cancer prevalent area, high-quality endoscopic examination is required not to overlook pathologic lesions. Endoscopic biopsy is the gold standard for the confirmation of endoscopic diagnosis. It is usually decided based on the abnormal morphology of the lesions or color change of the mucosa. Diagnostic accuracy is known to be improved by training or using optical techniques or chromoendoscopy. With the development of endoscopic imaging technologies such as narrow band imaging (NBI), confocal imaging or magnifying techniques, the diagnostic accuracy can be enhanced. However, inspection with conventional white light endoscopy is still the most prevalent and basic form of screening or surveillance endoscopy. Thus, detecting lesions by meticulous inspection and accurate approach by targeted biopsy are important for the diagnosis of pathologic lesions. However, the optimal number of biopsy and the detection rate of neoplastic lesions are not established. This study aimed at evaluating the current practice pattern and effect of training in conventional upper endoscopic biopsy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faculty doctors | – | Other: No interventionExperienced endoscopists (> 6000 cases). no intervention |
| Trainees | – | Other: No interventionDoctors on fellowship who are inexperienced endoscopists (< 4 months of endoscopy training) no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From May to July 2013, all the biopsy specimens from diagnostic esophagogastroduodenoscopy will be collected and analyzed in a single teaching hospital of Korea.
Key inclusion criteria (1 listed)
- Diagnostic EGD including screening endoscopy for health check-up or endoscopic examinations for the symptomatic patients to make a diagnosis.
Key exclusion criteria (1 listed)
- Specimens from therapeutic procedures, such as endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)
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 |
|---|---|---|
| No interventionretrospective data review | Other | Faculty doctors, Trainees |
Primary outcome
Concordance rate of endoscopic diagnosis and histologic diagnosis
Time frame: During 3 months (retrospective endoscopy data review)
In the evaluation of concordance rate and discrepancy rate, endoscopic diagnosis in the procedure report and histologic diagnosis in the pathology report will be compared.
1 secondary outcome
Neoplastic lesion detection rate
Time frame: During 3 months (retrospetive endoscopy data review)
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 25 Oct 2018.
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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.
Chang Seok Bang, MD principal investigator
Department of Internal Medicine, Hallym University College of Medicine, Korea
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 Neoplasm, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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 1 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 25 Oct 2018. 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 South Korea. 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?
Concordance rate of endoscopic diagnosis and histologic diagnosis (time frame: During 3 months (retrospective endoscopy data review)). 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 25 Oct 2018.