Gastric Intestinal MetaplasiaPhase 1NCT02806115
The Efficacy of Severe Whitening and Delayed Fading in Acetic Acid-enhanced Endoscopy for Diagnosing Gastric Intestinal Metaplasia
A Phase 1 study testing acetic acid-enhanced endoscopy, Acetic Acid and endoscope in people with Gastric Intestinal Metaplasia, run by Shandong University at 1 site in China.
Trial summary
Investigators found that the degree and the duration of aceto-whitening differed between gastric intestinal metaplasia(GIM) and the surrounding normal mucosa: the area of GIM showed a severe degree of aceto whiteness and the whitening continued longer than the surrounding normal mucosa, which investigators called… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Intestinal Metaplasia
- What is being tested?
- acetic acid-enhanced endoscopy, Acetic Acid and endoscope
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Aug 2016
- Phase
- Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- long-lasting upper gastrointestinal symptoms (>15 years)
- atrophic gastritis or GIM identified at surveillance endoscopy
Who cannot join
- presence of advanced adenocarcinoma in the stomach
- presence of acute gastrointestinal bleeding
- presence of coagulopathy, uncontrolled impaired renal or liver disease
- presence of pregnancy or lactation
- presence of allergy to acetic acid
- age younger than 18 years or older than 80 years
- inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Xiuli Zuo, PhD, 15588818685 ext. 053188369277, zuoxiuli@sina.com
Lidong Xu, MD
About this study
Investigators found that the degree and the duration of aceto-whitening differed between gastric intestinal metaplasia(GIM) and the surrounding normal mucosa: the area of GIM showed a severe degree of aceto whiteness and the whitening continued longer than the surrounding normal mucosa, which investigators called "severe whitening" and "delayed fading", and investigators realized that GIM could possibly be diagnosed by using these differences.The aim of this prospective study was to investigate the efficacy of "severe whitening" and "delayed fading" for diagnosing GIM.
- Conditions
- Gastric Intestinal Metaplasia
- Being tested
- acetic acid-enhanced endoscopy, Acetic Acid, endoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetic acid-enhanced endoscopyProcedure or surgery
Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.
Acetic AcidDrug
The concentration of acetic acid used in this study is 1.5%.
endoscopeDevice
This study using an EG-29-i10 endoscope (Pentax, Tokyo, Japan) and an EPK-i7010 processor (Pentax, Tokyo, Japan).
| Study group | Role | What they receive |
|---|---|---|
| acetic acid-enhanced endoscopy | Experimental | Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid. Receives: Procedure: acetic acid-enhanced endoscopy; Drug: Acetic Acid; Device: endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of "severe whitening" for diagnosing gastric intestinal metaplasia
Measured: 6 months
accuracy of "delayed fading" for diagnosing gastric intestinal metaplasia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJun 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806115
- Sponsor's protocol ID
- 2015SDU-QILU-G003
- Status last verified
- Jun 2016
- First submitted
- 5 Jun 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Severe Whitening and Delayed Fading in Acetic Acid-enhanced Endoscopy for Diagnosing Gastric Intestinal Metaplasia
- ClinicalTrials.gov ID
- NCT02806115
- Acronym / sponsor ID
- 2015SDU-QILU-G003
- Conditions
- Gastric Intestinal Metaplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (estimated)
- First posted
- 20 Jun 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.
Investigators found that the degree and the duration of aceto-whitening differed between gastric intestinal metaplasia(GIM) and the surrounding normal mucosa: the area of GIM showed a severe degree of aceto whiteness and the whitening continued longer than the surrounding normal mucosa, which investigators called "severe whitening" and "delayed fading", and investigators realized that GIM could possibly be diagnosed by using these differences.The aim of this prospective study was to investigate the efficacy of "severe whitening" and "delayed fading" for diagnosing GIM.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acetic acid-enhanced endoscopy | Experimental | Procedure: acetic acid-enhanced endoscopy, Drug: Acetic Acid, Device: endoscopeAcetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- long-lasting upper gastrointestinal symptoms (>15 years)
- atrophic gastritis or GIM identified at surveillance endoscopy
Key exclusion criteria (7 listed)
- presence of advanced adenocarcinoma in the stomach
- presence of acute gastrointestinal bleeding
- presence of coagulopathy, uncontrolled impaired renal or liver disease
- presence of pregnancy or lactation
- presence of allergy to acetic acid
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 |
|---|---|---|
| acetic acid-enhanced endoscopyAcetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid. | Procedure or surgery | acetic acid-enhanced endoscopy |
| Acetic AcidThe concentration of acetic acid used in this study is 1.5%. | Drug | acetic acid-enhanced endoscopy |
| endoscopeThis study using an EG-29-i10 endoscope (Pentax, Tokyo, Japan) and an EPK-i7010 processor (Pentax, Tokyo, Japan). | Device | acetic acid-enhanced endoscopy |
Primary outcome
accuracy of "severe whitening" for diagnosing gastric intestinal metaplasia
Time frame: 6 months
accuracy of "delayed fading" for diagnosing gastric intestinal metaplasia
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 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.
Xiuli Zuo, PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing acetic acid-enhanced endoscopy, Acetic Acid and endoscope 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 2 inclusion and 7 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 20 Jun 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiuli Zuo, PhD (15588818685 ext. 053188369277, zuoxiuli@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of "severe whitening" for diagnosing gastric intestinal metaplasia (time frame: 6 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 20 Jun 2016.