Stomach NeoplasmsNCT01508520
a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions
An observational study of Stomach Neoplasms, run by Xiaobo Li.
Trial summary
Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI for differential diagnosis among early gastric cancers (EGC) have not been fully established.The study is based on the hypothesis: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stomach Neoplasms
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Dec 2011
- 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: patients with gastric lesions suspected of early gastric malignancy
Who may be able to join
- patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy.
Who cannot join
- advanced gastric cancer or any other malignancy;
- patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc;
- inability to provide informed consent;
- inability to provide histology of resected specimens after endoscopic treatment or surgery.
About this study
Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI for differential diagnosis among early gastric cancers (EGC) have not been fully established.The study is based on the hypothesis:
- ME-NBI is useful in distinguishing EGC from other gastric lesions
- ME-NBI is useful in further differential diagnosis among EGCs.
- Conditions
- Stomach Neoplasms
- Keywords
- early gastric cancer, stomach neoplasms, magnifying endoscopy, narrow band imaging
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis accuracy of ME-NBI
ME-NBI diagnosis was made during real-time endoscopy procedure and reviewed in two weeks after ME-NBI examination. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ME-NBI diagnosis compared with histology were measured.
Measured: in 2 weeks after ME-NBI examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startDec 2009
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaobo Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaobo Li, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xiaobo Li, MD. Ph.D, Principal investigator, Shanghai Ren Ji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508520
- Sponsor's protocol ID
- rjyyxhk6056
- Status last verified
- Jan 2012
- First submitted
- 8 Jan 2012
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions
- ClinicalTrials.gov ID
- NCT01508520
- Acronym / sponsor ID
- rjyyxhk6056
- Conditions
- Stomach Neoplasms
- Keywords
- early gastric cancer, stomach neoplasms, magnifying endoscopy, narrow band imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Xiaobo LiUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Jan 2012 (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.
Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI for differential diagnosis among early gastric cancers (EGC) have not been fully established.The study is based on the hypothesis:
- ME-NBI is useful in distinguishing EGC from other gastric lesions
- ME-NBI is useful in further differential diagnosis among EGCs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with gastric lesions suspected of early gastric malignancy
Key inclusion criteria (1 listed)
- patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy.
Key exclusion criteria (4 listed)
- advanced gastric cancer or any other malignancy;
- patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc;
- inability to provide informed consent;
- inability to provide histology of resected specimens after endoscopic treatment or surgery.
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
diagnosis accuracy of ME-NBI
Time frame: in 2 weeks after ME-NBI examination
ME-NBI diagnosis was made during real-time endoscopy procedure and reviewed in two weeks after ME-NBI examination. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ME-NBI diagnosis compared with histology were measured.
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 12 Jan 2012.
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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.
Xiaobo Li, MD. Ph.D principal investigator
Shanghai Ren Ji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms, run by Xiaobo Li.
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 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: finished, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
diagnosis accuracy of ME-NBI (time frame: in 2 weeks after ME-NBI examination). 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 12 Jan 2012.