Gastric Intestinal MetaplasiaNCT03672708
Confocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia
A study testing Cresyl violet in people with Gastric Intestinal Metaplasia, run by Shandong University at 1 site in China.
Trial summary
Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Intestinal Metaplasia
- What is being tested?
- Cresyl violet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2018to 2 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who had long-lasting upper gastrointestinal symptoms and aged 40 years or above
- patients with H. pylori infection, or known GIM or atrophic gastritis
Who cannot join
- patients with a history of GI surgery
- advanced gastric carcinoma or any other malignancy in the GI tract
- acute upper GI bleeding
- patients with contraindications to CLE examination, such as coagulopathy, pregnancy, breast feeding, impaired renal or liver function
- patients refused to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
Official title: Cresyl Violet as a New Contrast Agent in Confocal Laser Endomicroscopy for in Vivo Diagnosis of Gastric Intestinal Metaplasia
Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been used in CLE to visualize tissue architecture in human ileum, colon or myenteric plexus.No investigation has reported the characterization of GIM imaged with CLE when using CV as staining dye
- Conditions
- Gastric Intestinal Metaplasia
- Being tested
- Cresyl violet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cresyl violetDiagnostic test
cresyl violet is applicated at the concentration of 0.15% via a spraying catheter to visualize cellular and tissue architecture in the pCLE
| Study group | Role | What they receive |
|---|---|---|
| Cresyl violet | Other | Not described Receives: Diagnostic Test: Cresyl violet |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of CV for identifying GIM
ratio of pCLE failure to visualize the cellular and subcellular structures
Measured: 1 month
feasibility of CV for identifying GIM
ratio of pCLE failure to recognize lesions and their immediate characterization
Measured: 1 month
newly pCLE criteria with CV application for GIM
ratio of diagnostic agreement between pCLE using CV and histopathological results
Measured: 1 month
newly pCLE criteria with CV application for GIM
number of diagnostic agreement between pCLE with CV application and histopathological results
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start16 Sep 2018
- Primary completion26 Oct 2018
- Study completion2 Jan 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
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 UniversityZhen Li, PhD,MD, Study director, Department of Gastroenterology,Qilu Hospital,shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672708
- Sponsor's protocol ID
- 2018SDU-QILU-06
- Status last verified
- Sep 2018
- First submitted
- 3 Aug 2018
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cresyl Violet as a New Contrast Agent in Confocal Laser Endomicroscopy for in Vivo Diagnosis of Gastric Intestinal Metaplasia
- ClinicalTrials.gov ID
- NCT03672708
- Acronym / sponsor ID
- 2018SDU-QILU-06
- Conditions
- Gastric Intestinal Metaplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 16 Sep 2018 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 14 Sep 2018 (actual)
- 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.
Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been used in CLE to visualize tissue architecture in human ileum, colon or myenteric plexus.No investigation has reported the characterization of GIM imaged with CLE when using CV as staining dye
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cresyl violet | Other | Diagnostic Test: Cresyl violet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who had long-lasting upper gastrointestinal symptoms and aged 40 years or above
- patients with H. pylori infection, or known GIM or atrophic gastritis
Key exclusion criteria (5 listed)
- patients with a history of GI surgery
- advanced gastric carcinoma or any other malignancy in the GI tract
- acute upper GI bleeding
- patients with contraindications to CLE examination, such as coagulopathy, pregnancy, breast feeding, impaired renal or liver function
- patients refused 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 |
|---|---|---|
| Cresyl violetcresyl violet is applicated at the concentration of 0.15% via a spraying catheter to visualize cellular and tissue architecture in the pCLE | Diagnostic test | Cresyl violet |
Primary outcome
feasibility of CV for identifying GIM
Time frame: 1 month
ratio of pCLE failure to visualize the cellular and subcellular structures
feasibility of CV for identifying GIM
Time frame: 1 month
ratio of pCLE failure to recognize lesions and their immediate characterization
newly pCLE criteria with CV application for GIM
Time frame: 1 month
ratio of diagnostic agreement between pCLE using CV and histopathological results
newly pCLE criteria with CV application for GIM
Time frame: 1 month
number of diagnostic agreement between pCLE with CV application and histopathological results
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 14 May 2019.
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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
Zhen 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 Cresyl violet 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 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 14 May 2019. 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?
feasibility of CV for identifying GIM (time frame: 1 month). The study lists 4 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 14 May 2019.