Stomach NeoplasmsCLENCT00851305
Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy
A study testing Endomicroscope (Pentax, Tokyo, Japan) and Gastroscopes (Pentax, Tokyo, Japan) in people with Stomach Neoplasms and Precancerous Conditions, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC). Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stomach Neoplasms, Precancerous Conditions
- What is being tested?
- Endomicroscope (Pentax, Tokyo, Japan) and Gastroscopes (Pentax, Tokyo, Japan)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,786 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Jul 2009
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years old ≤ age < 80 years old
- Patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy
Who cannot join
- Known cancers or gastrectomy
- Scheduled for endoscopic treatment
- Alarm symptoms such as dysphagia, anaemia, gastrointestinal bleeding or obstruction, marked weight loss
- Under conditions such as:
- ascites
- jaundice
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- liver cirrhosis
- impaired renal function
- coagulopathy
- fever
- pregnancy
- breastfeeding
- Inability to provide informed consent
- Known allergy to fluorescein sodium
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: Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers
The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).
Read the detailed description
Endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (GC). Confocal laser endomicroscopy (CLE), a new diagnostic modality, has been shown to be valuable in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether CLE is helpful to find out early gastric cancer (EGC).The aim of the study is to investigate the value of CLE in improving the detection of EGCs.
- Conditions
- Stomach Neoplasms, Precancerous Conditions
- Being tested
- Endomicroscope (Pentax, Tokyo, Japan), Gastroscopes (Pentax, Tokyo, Japan)
- Keywords
- Stomach, endoscopy, neoplasms
- Medical subject headings
- Stomach Neoplasms, Precancerous Conditions, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endomicroscope (Pentax, Tokyo, Japan)Device
Also called Pentax EC3870K endomicroscope
A Pentax EC3870K endomicroscope which can produce conventional white light endoscopic images and confocal images at the same time with a optical slice thickness of 7 μm, a lateral resolution of 0.7 μm, a scanning depth of 0 to 250 μm, a pixel density of 1024×512 pixels (at an image acquisition rate of 1.6 frames/second)，and a field of view of 475 μm×475 μm.
Gastroscopes (Pentax, Tokyo, Japan)Device
Also called Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)
Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)
| Study group | Role | What they receive |
|---|---|---|
| 1 confocal laser endomicroscopy | Experimental | Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy. Receives: Device: Endomicroscope (Pentax, Tokyo, Japan) |
| 2 Conventional endoscopy | Active comparator | Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy. Receives: Device: Gastroscopes (Pentax, Tokyo, Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.
Measured: one year
Secondary outcomes (1)
To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionJul 2009
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.
- 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
- None (open label)
- Enrolment
- 1,786 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851305
- Sponsor's protocol ID
- 2008SDU-QILU-G01
- Other IDs
- 2006GG3202022, 2007(Ministry of Health)
- Acronym
- CLE
- Status last verified
- Jul 2012
- First submitted
- 24 Feb 2009
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers
- ClinicalTrials.gov ID
- NCT00851305
- Acronym / sponsor ID
- CLE / 2008SDU-QILU-G01
- Conditions
- Stomach Neoplasms, Precancerous Conditions
- Keywords
- Stomach, endoscopy, neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,786 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 25 Feb 2009 (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 determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).
Detailed description
Endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (GC). Confocal laser endomicroscopy (CLE), a new diagnostic modality, has been shown to be valuable in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether CLE is helpful to find out early gastric cancer (EGC).The aim of the study is to investigate the value of CLE in improving the detection of EGCs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 confocal laser endomicroscopy | Experimental | Device: Endomicroscope (Pentax, Tokyo, Japan)Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy. |
| 2 Conventional endoscopy | Active comparator | Device: Gastroscopes (Pentax, Tokyo, Japan)Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 45 years old ≤ age < 80 years old
- Patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy
Key exclusion criteria (14 listed)
- Known cancers or gastrectomy
- Scheduled for endoscopic treatment
- Alarm symptoms such as dysphagia, anaemia, gastrointestinal bleeding or obstruction, marked weight loss
- Under conditions such as:
- 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 |
|---|---|---|
| Endomicroscope (Pentax, Tokyo, Japan)Also: Pentax EC3870K endomicroscopeA Pentax EC3870K endomicroscope which can produce conventional white light endoscopic images and confocal images at the same time with a optical slice thickness of 7 μm, a lateral resolution of 0.7 μm, a scanning depth of 0 to 250 μm, a pixel density of 1024×512 pixels (at an image acquisition rate of 1.6 frames/second)，and a field of view of 475 μm×475 μm. | Device | 1 confocal laser endomicroscopy |
| Gastroscopes (Pentax, Tokyo, Japan)Also: Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)Conventional white light gastroscopes (Pentax EG-2940 gastroscopes) | Device | 2 Conventional endoscopy |
Primary outcome
To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.
Time frame: one year
1 secondary outcome
To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.
Time frame: one year
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 17 Jul 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.
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 Endomicroscope (Pentax, Tokyo, Japan) and Gastroscopes (Pentax, Tokyo, Japan) in people with Stomach Neoplasms and Precancerous Conditions, 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 14 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 17 Jul 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?
To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy. (time frame: one year). 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 17 Jul 2012.