Stomach NeoplasmsNCT01617876
Enhanced Magnifying Endoscopy for Diagnosis of Early Gastric Cancer
An observational study of Stomach Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
When performing screening endoscopy, small focal gastric lesions are frequently encountered. Novel techniques in endoscopy, such as magnifying endoscopy (ME) with narrow-band imaging (NBI) and chromoendoscopy with acetic acid-indigocarmine mixture (AIM), are developing to enhance images of gastrointestinal tumor. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Stomach Neoplasms
- How many people
- 282 participants
- Where
- 1 siteChina
- Study dates
- Mar 2010to Mar 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible for inclusion.
Who may be able to join
- Patients, in which small focal gastric lesions were identified with conventional WLE, were enrolled in this study. Before being enrolled, all patients provided written informed consent.
Who cannot join
- Patients who cannot undergo gastroscopies due to unsuitable conditions
- Referred patients with a history of having being diagnosed as gastric cancer
- Patients with a personal history of gastric surgery
- Patients who cannot provide informed consent
- Patients with advanced gastric cancer
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Peking Union Medical College Hospital
Beijing, 100730
About this study
Official title: A Prospective Study on the Accuracy of Enhanced Magnifying Endoscopy for Differential Diagnosis of Small Focal Gastric Lesions Identified With White-light Endoscopy
When performing screening endoscopy, small focal gastric lesions are frequently encountered. Novel techniques in endoscopy, such as magnifying endoscopy (ME) with narrow-band imaging (NBI) and chromoendoscopy with acetic acid-indigocarmine mixture (AIM), are developing to enhance images of gastrointestinal tumor. Furthermore, observation of the microstructures of gastric mucosa by ME, including microvascular pattern and microsurface pattern, has been proposed in the recognition of early gastric cancer (EGC).
This study is based on the hypothesis as follow:
- The microvascular structure could be clearly observed with magnifying endoscopy enhanced by narrow-band imaging (ME-NBI).
- The microsurface architecture could be clearly observed with magnifying endoscopy enhanced by acetic acid-indigocarmine mixture (ME-AIM).
- Enhanced ME (combining ME-NBI and ME-AIM), as compared to white-light endoscopy (WLE), has higher sensitivity and specificity for the differential diagnosing small focal gastric lesions.
Read the detailed description
Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible for inclusion. WLE without magnification was performed first in eligible patients. Based on an assessment of the shape (such as flat, depressed or elevated) and color (pale or reddened), small focal gastric lesions were identified and included for evaluation by experienced endoscopists. When such a lesion was detected during non-magnifying observation with WLE, the mode was then changed to ME-NBI for observation of microvascular pattern and ME-AIM for observation of microsurface pattern subsequently. All endoscopic images of the whole procedure were recorded in digital filing system for later evaluation. To avoid possible selection bias and to maintain the quality of the study, all images of each endoscopic modality (including WLE, ME-NBI, ME-AIM), which were arranged randomly on one slide and displayed independently of the images of other endoscopic modality, were evaluated by 4 skilled endoscopists, who were not access to the clinical and pathological data. The general consensus was established for an assessment of each lesion. Two forceps biopsy specimens were taken from each lesion and pathological diagnosis were used as the criterion standard for cancer diagnosis.
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms, early gastric cancer, magnifying endoscopy, narrow band imaging, acetic acid, indigocarmine
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of enhanced ME (combining ME-NBI and ME-AIM)
Enhanced ME diagnosis was made subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of sensitivity, specificity, positive predictive value and negative predictive value of enhanced ME diagnosis compared with histopathology diagnosis were measured.
Measured: 1 week
Secondary outcomes (3)
Diagnostic accuracy of WLE
WLE diagnosis was made subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of sensitivity, specificity, positive predictive value and negative predictive value of WLE diagnosis compared with histopathology diagnosis were measured.
Measured: 1 week
The relationships between the microvascular patterns and the histopathological findings
The microvascular pattern of each lesion was evaluated subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of distribution of different microvascular patterns compared with histopathology diagnosis was measured.
Measured: 1 week
The relationships between the microsurface patterns and the histopathological findings
The microsurface pattern of each lesion was evaluated subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of distribution of different microsurface patterns compared with histopathology diagnosis was measured.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionMar 2012
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.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Xinghua Lu, Peking Union Medical College Hospital
- Investigators
- Xinghua Lu, Dr, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01617876
- Sponsor's protocol ID
- LXH-EGC-1
- Other IDs
- 200902002
- Status last verified
- Jun 2012
- First submitted
- 9 Jun 2012
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Accuracy of Enhanced Magnifying Endoscopy for Differential Diagnosis of Small Focal Gastric Lesions Identified With White-light Endoscopy
- ClinicalTrials.gov ID
- NCT01617876
- Acronym / sponsor ID
- LXH-EGC-1
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms, early gastric cancer, magnifying endoscopy, narrow band imaging, acetic acid, indigocarmine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Jun 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.
When performing screening endoscopy, small focal gastric lesions are frequently encountered. Novel techniques in endoscopy, such as magnifying endoscopy (ME) with narrow-band imaging (NBI) and chromoendoscopy with acetic acid-indigocarmine mixture (AIM), are developing to enhance images of gastrointestinal tumor. Furthermore, observation of the microstructures of gastric mucosa by ME, including microvascular pattern and microsurface pattern, has been proposed in the recognition of early gastric cancer (EGC).
This study is based on the hypothesis as follow:
- The microvascular structure could be clearly observed with magnifying endoscopy enhanced by narrow-band imaging (ME-NBI).
- The microsurface architecture could be clearly observed with magnifying endoscopy enhanced by acetic acid-indigocarmine mixture (ME-AIM).
- Enhanced ME (combining ME-NBI and ME-AIM), as compared to white-light endoscopy (WLE), has higher sensitivity and specificity for the differential diagnosing small focal gastric lesions.
Detailed description
Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible for inclusion. WLE without magnification was performed first in eligible patients. Based on an assessment of the shape (such as flat, depressed or elevated) and color (pale or reddened), small focal gastric lesions were identified and included for evaluation by experienced endoscopists. When such a lesion was detected during non-magnifying observation with WLE, the mode was then changed to ME-NBI for observation of microvascular pattern and ME-AIM for observation of microsurface pattern subsequently. All endoscopic images of the whole procedure were recorded in digital filing system for later evaluation. To avoid possible selection bias and to maintain the quality of the study, all images of each endoscopic modality (including WLE, ME-NBI, ME-AIM), which were arranged randomly on one slide and displayed independently of the images of other endoscopic modality, were evaluated by 4 skilled endoscopists, who were not access to the clinical and pathological data. The general consensus was established for an assessment of each lesion. Two forceps biopsy specimens were taken from each lesion and pathological diagnosis were used as the criterion standard for cancer diagnosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible for inclusion.
Key inclusion criteria (1 listed)
- Patients, in which small focal gastric lesions were identified with conventional WLE, were enrolled in this study. Before being enrolled, all patients provided written informed consent.
Key exclusion criteria (5 listed)
- Patients who cannot undergo gastroscopies due to unsuitable conditions
- Referred patients with a history of having being diagnosed as gastric cancer
- Patients with a personal history of gastric surgery
- Patients who cannot provide informed consent
- Patients with advanced gastric cancer
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
Diagnostic accuracy of enhanced ME (combining ME-NBI and ME-AIM)
Time frame: 1 week
Enhanced ME diagnosis was made subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of sensitivity, specificity, positive predictive value and negative predictive value of enhanced ME diagnosis compared with histopathology diagnosis were measured.
3 secondary outcomes
Diagnostic accuracy of WLE
Time frame: 1 week
The relationships between the microvascular patterns and the histopathological findings
Time frame: 1 week
The relationships between the microsurface patterns and the histopathological findings
Time frame: 1 week
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 Jun 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.
Xinghua Lu, Dr principal investigator
Peking Union Medical College 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 Stomach Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.
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 5 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 Jun 2012. 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 China. 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?
Diagnostic accuracy of enhanced ME (combining ME-NBI and ME-AIM) (time frame: 1 week). 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 Jun 2012.