Gastric Intestinal MetaplasiaNCT02725034
Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement
A study testing Standard endoscopy and High definition endoscopy with Optic Enhancement in people with Gastric Intestinal Metaplasia, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Gastric Intestinal Metaplasia
- What is being tested?
- Standard endoscopy and High definition endoscopy with Optic Enhancement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Aug 2016
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with dyspeptic symptoms and aged 40 years or older
- or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
- or patients with family history of gastric cancer
Who cannot join
- presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
- presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, PhD. MD., 18678827666 ext. 82169508, qiluliyanqing@gmail.com
About this study
The purpose of this study is to assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield
Read the detailed description
Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended. However, the updated Sydney System biopsy protocol needs more biopsy number and procedure time, for it is unable to satisfy the diagnosis of gastric intestinal metaplasia. Optic Enhancement is a novel image-enhanced endoscopy system. Targeted biopsy protocol based on high definition endoscopy with Optic Enhancement will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from high definition endoscopy with Optic Enhancement targeted biopsies and a standard biopsy protocol and assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.
- Conditions
- Gastric Intestinal Metaplasia
- Being tested
- Standard endoscopy, High definition endoscopy with Optic Enhancement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard endoscopyDevice
High definition endoscopy with Optic EnhancementDevice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Standard endoscopy with a standard biopsy protocol from the five standard biopsy sites following the updated Sydney System including two from the distal antrum (within 2-3cm from the pylorus, greater/lesser curvature), one from the incisura and two from the mid corpus (greater/lesser curvature). Receives: Device: Standard endoscopy |
| Group 2 | Experimental | High definition endoscopy with Optic Enhancement targeted biopsies for gastric intestinal metaplasia. Receives: Device: High definition endoscopy with Optic Enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-patient analysis
Measured: eight months
Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-biopsy analysis
Measured: eight months
Secondary outcomes (1)
Number of biopsies needed in per group
Measured: eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, PhD. MD., Study director, Department of Gastroenterology, Qilu Hospital, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725034
- Sponsor's protocol ID
- 2016SDU-QILU-02
- Status last verified
- Mar 2016
- First submitted
- 26 Mar 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Gastric Intestinal Metaplasia With High Definition Endoscopy and Optic Enhancement
- ClinicalTrials.gov ID
- NCT02725034
- Acronym / sponsor ID
- 2016SDU-QILU-02
- Conditions
- Gastric Intestinal Metaplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (estimated)
- First posted
- 31 Mar 2016 (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 purpose of this study is to assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield
Detailed description
Gastric intestinal metaplasia is regarded as an important premalignant lesion for intestinal type gastric cancer. Currently, the histological assessment of gastric intestinal metaplasia still relies on the biopsies took from five sites that the updated Sydney System recommended. However, the updated Sydney System biopsy protocol needs more biopsy number and procedure time, for it is unable to satisfy the diagnosis of gastric intestinal metaplasia. Optic Enhancement is a novel image-enhanced endoscopy system. Targeted biopsy protocol based on high definition endoscopy with Optic Enhancement will be possible for the diagnosis of gastric intestinal metaplasia. This study aims to compare the diagnostic yield of gastric intestinal metaplasia from high definition endoscopy with Optic Enhancement targeted biopsies and a standard biopsy protocol and assess whether high definition endoscopy with Optic Enhancement can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Standard endoscopyStandard endoscopy with a standard biopsy protocol from the five standard biopsy sites following the updated Sydney System including two from the distal antrum (within 2-3cm from the pylorus, greater/lesser curvature), one from the incisura and two from the mid corpus (greater/lesser curvature). |
| Group 2 | Experimental | Device: High definition endoscopy with Optic EnhancementHigh definition endoscopy with Optic Enhancement targeted biopsies for gastric intestinal metaplasia. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with dyspeptic symptoms and aged 40 years or older
- or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
- or patients with family history of gastric cancer
Key exclusion criteria (3 listed)
- presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
- presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
- inability to provide informed consent
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 |
|---|---|---|
| Standard endoscopy | Device | Group 1 |
| High definition endoscopy with Optic Enhancement | Device | Group 2 |
Primary outcome
Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-patient analysis
Time frame: eight months
Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-biopsy analysis
Time frame: eight months
1 secondary outcome
Number of biopsies needed in per group
Time frame: eight months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
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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.
Yanqing Li, PhD. MD. study director
Department of Gastroenterology, Qilu Hospital, Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard endoscopy and High definition endoscopy with Optic Enhancement in people with Gastric Intestinal Metaplasia, run by Shandong University 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 3 inclusion and 3 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 31 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, PhD. MD. (18678827666, qiluliyanqing@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the detection rate of gastric intestinal metaplasia between high definition endoscopy with Optic Enhancement targeted biopsies and standard endoscopy with standard biopsy protocol in a per-patient analysis (time frame: eight months). The study lists 2 primary outcomes in all. 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 31 Mar 2016.