Gastric CancerNCT01896310
New Classification of Stomach Using Probe-based Confocal Laser Endomicroscopy
An observational study of Gastric Cancer and Intestinal Metaplasia, run by Shandong University at 1 site in China.
Trial summary
The aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Intestinal Metaplasia, Atrophic Gastritis
- What is being tested?
- probe-based confocal laser endomicroscopy
- Type of treatment
- Medical device
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Sep 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University
Who may be able to join
- patients scheduled for pCLE examination
- aged between 18 and 80 years old
Who cannot join
- Esophageal, gastric or duodenal cancer or other malignancy
- History of upper GI tract surgery
- Coagulopathy or bleeding disorders
- Allergy to fluorescein sodium
- Pregnant or breast-feeding (for females)
- Impaired renal function
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: New Classification of Gastric Pit Patterns and Vessel Architecture Using Probe-based Confocal Laser Endomicroscopy
The aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.
Read the detailed description
Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device which allows the application of laser microscopy with any conventional endoscope and mosaic imaging. Previous studies have demonstrated its application in various GI diseases, including Barrett's esophagus, colonic adenoma, ulcerative colitis, and etc. However, limited data are provided on exploring the application of pCLE in the stomach. Therefore, the aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.
- Being tested
- probe-based confocal laser endomicroscopy
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probe-based confocal laser endomicroscopyDevice
all patients will receive pCLE examination
| Study group | Role | What they receive |
|---|---|---|
| pCLE examination | patients will be prospectively recruited and examined first with high-definition endoscopy (EG-2990i, Pentax, Japan) followed by probe-based confocal laser endomicroscopy Receives: Device: probe-based confocal laser endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy of the new classification system
Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of the new classification of gastric pit patterns and vessel architecture using probe-based confocal laser endomicroscopy
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 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, MD.PhD., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896310
- Sponsor's protocol ID
- 2013SDU-QILU-G01
- Status last verified
- May 2014
- First submitted
- 28 Jun 2013
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Classification of Gastric Pit Patterns and Vessel Architecture Using Probe-based Confocal Laser Endomicroscopy
- ClinicalTrials.gov ID
- NCT01896310
- Acronym / sponsor ID
- 2013SDU-QILU-G01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 11 Jul 2013 (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 aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.
Detailed description
Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device which allows the application of laser microscopy with any conventional endoscope and mosaic imaging. Previous studies have demonstrated its application in various GI diseases, including Barrett's esophagus, colonic adenoma, ulcerative colitis, and etc. However, limited data are provided on exploring the application of pCLE in the stomach. Therefore, the aim of the present study was to propose a new pCLE classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pCLE classification system in the stomach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pCLE examination | – | Device: probe-based confocal laser endomicroscopypatients will be prospectively recruited and examined first with high-definition endoscopy (EG-2990i, Pentax, Japan) followed by probe-based confocal laser endomicroscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective patients scheduled for pCLE examination at Qilu Hospital, Shandong University
Key inclusion criteria (2 listed)
- patients scheduled for pCLE examination
- aged between 18 and 80 years old
Key exclusion criteria (6 listed)
- Esophageal, gastric or duodenal cancer or other malignancy
- History of upper GI tract surgery
- Coagulopathy or bleeding disorders
- Allergy to fluorescein sodium
- Pregnant or breast-feeding (for females)
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 |
|---|---|---|
| probe-based confocal laser endomicroscopyall patients will receive pCLE examination | Device | pCLE examination |
Primary outcome
The diagnostic accuracy of the new classification system
Time frame: 3 month
Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of the new classification of gastric pit patterns and vessel architecture using probe-based confocal laser endomicroscopy
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 13 May 2014.
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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, MD.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?
An observational study of Gastric Cancer and 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 6 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 13 May 2014. 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?
The diagnostic accuracy of the new classification system (time frame: 3 month). 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 13 May 2014.