Intestinal MetaplasiaNCT01024621
Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial
A study testing Endomicroscope and Standard endoscopy in people with Intestinal Metaplasia, run by Shandong University at 1 site in China.
Trial summary
The purpose of this study is to assess whether confocal laser endomicroscopy 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
- Intestinal Metaplasia
- What is being tested?
- Endomicroscope and Standard endoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Jul 2010
- 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
- 40 years old ≤ age < 80 years old
- Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia
- Able to give informed consent.
Who cannot join
- Esophageal, gastric or duodenal cancer or other malignancy
- Known GIM or intraepithelial neoplasia in upper GI tract
- Scheduled for endoscopic therapy
- History of upper GI tract surgery
- Reflux esophagitis or acute gastritis or peptic ulcers
- Acute upper gastrointestinal bleeding
Show all 10Show fewer
- 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: Comparison of Confocal Laser Endomicroscopy With Standard Endoscopy for the Detection and Evaluation of Gastric Intestinal Metaplasia in a High Risk Population: A Randomized Controlled Trial
The purpose of this study is to assess whether confocal laser endomicroscopy 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 a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.
- Conditions
- Intestinal Metaplasia
- Being tested
- Endomicroscope, Standard endoscopy
- Keywords
- gastric intestinal metaplasia, Confocal laser endomicroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndomicroscopeDevice
Also called Pentax EC3870K endomicroscope
Pentax EC3870K, Tokyo, Japan
Standard endoscopyDevice
Also called Pentax EC2931 gastroscope (Pentax, Tokyo, Japan)
Pentax EG-2931 gastroscope
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | confocal laser endomicroscopy Receives: Device: Endomicroscope |
| 2 | Active comparator | standard endoscopy Receives: Device: Standard endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic yield of gastric intestinal metaplasia
Measured: Seven months
Secondary outcomes (1)
the biopsy number needed in each group
Measured: Seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 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
- NCT01024621
- Sponsor's protocol ID
- 2009SDU-QILU-G06
- Status last verified
- Jul 2012
- First submitted
- 2 Dec 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 of Confocal Laser Endomicroscopy With Standard Endoscopy for the Detection and Evaluation of Gastric Intestinal Metaplasia in a High Risk Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01024621
- Acronym / sponsor ID
- 2009SDU-QILU-G06
- Conditions
- Intestinal Metaplasia
- Keywords
- gastric intestinal metaplasia, Confocal laser endomicroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 3 Dec 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 assess whether confocal laser endomicroscopy 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 a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Endomicroscopeconfocal laser endomicroscopy |
| 2 | Active comparator | Device: Standard endoscopystandard endoscopy |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years old ≤ age < 80 years old
- Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia
- Able to give informed consent.
Key exclusion criteria (10 listed)
- Esophageal, gastric or duodenal cancer or other malignancy
- Known GIM or intraepithelial neoplasia in upper GI tract
- Scheduled for endoscopic therapy
- History of upper GI tract surgery
- Reflux esophagitis or acute gastritis or peptic ulcers
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 |
|---|---|---|
| EndomicroscopeAlso: Pentax EC3870K endomicroscopePentax EC3870K, Tokyo, Japan | Device | 1 |
| Standard endoscopyAlso: Pentax EC2931 gastroscope (Pentax, Tokyo, Japan)Pentax EG-2931 gastroscope | Device | 2 |
Primary outcome
the diagnostic yield of gastric intestinal metaplasia
Time frame: Seven months
1 secondary outcome
the biopsy number needed in each group
Time frame: Seven months
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 and Standard endoscopy in people with 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 10 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?
the diagnostic yield of gastric intestinal metaplasia (time frame: Seven months). 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; AzTrials last refreshed its copy on 8 Nov 2026.