Gastric Intestinal MetaplasiaNCT01642797
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma
A study testing Confocal laser endomicroscopy (Pentax, EG3870K) and Standard White-light endoscopy (Pentax, 90i) in people with Gastric Intestinal Metaplasia and Gastric Intraepithelial Neoplasia, run by Shandong University at 4 sites in 3 countries.
Trial summary
i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol. ii. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Intestinal Metaplasia, Gastric Intraepithelial Neoplasia, Gastric Carcinoma
- What is being tested?
- Confocal laser endomicroscopy (Pentax, EG3870K) and Standard White-light endoscopy (Pentax, 90i)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Aug 2012to Sep 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female aged 18-80
- Patients with H. pylori infection, or histologically verified gastric intestinal metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis
Who cannot join
- Patients with gastrectomy, acute GI bleeding, and advanced gastric cancer
- Patients under conditions unsuitable for performing CLE including coagulopathy, impaired renal function, pregnancy or breastfeeding, and known allergy to fluorescein sodium
- Inability to provide informed consent and other situations that could interfere with the examination protocol
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
China2 sites
the Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong, Hongkong
Joseph Jao-Yiu Sung, MD. PhD.
Joseph Jao-Yiu Sung, MD. PhD.
Qilu Hospital, Shandong University
Jinan, Shandong, 20012
Yanqing Li, MD. PhD.
Australia1 site
the University of New South Wales, Bankstown-Lidcombe Hospital
Bankstown
Rupert W. L. Leong, MD. PhD.
Rupert W Leong, MD. PhD.
Singapore1 site
National University Hospital, National University of Singapore
Singapore
Ho Khek Yu, MD. PhD.
Ho Khek Yu, MD. PhD.
About this study
Official title: Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma: A Multicenter, Randomized, Controlled Trial
- To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol. ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield. iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.
Read the detailed description
Gastric cancer remains the world's second leading cause of cancer-related deaths. The prognosis for patients with this cancer clearly depends on stage at diagnosis. At least for the intestinal subtype of gastric adenocarcinoma, a cascade of histopathologic lesions has been defined: chronic gastritis, atrophic chronic gastritis, intestinal metaplasia (IM), and intraepithelial neoplasia (IN). The identification of these lesions and follow-up of patients in whom they are found could lead to diagnosis of gastric cancer at an early stage, thus improving patients' survival. The diagnosis of these lesions, which often appear in flat mucosa, is currently based on histopathologic examination of endoscopic biopsy specimens. However, conventional white-light endoscopy (WLE) for this purpose has high interobserver variability and a poor correlation with histopathologic finding.
Confocal laser endomicroscopy (CLE), producing both conventional WLE and confocal microscopic images, can provide a direct histological observation of the in vivo tissue without the need for biopsy. Recently, CLE has shown its value for diagnosing gastric IM, intraepithelial neoplasia and carcinoma. However, none of those CLE criteria for gastric IM, IN or carcinoma (CA) has been validated in various endoscopic centers, hence reducing the reliability and clinical application of them.
- Being tested
- Confocal laser endomicroscopy (Pentax, EG3870K), Standard White-light endoscopy (Pentax, 90i)
- Keywords
- confocal laser endomicroscopy, gastric intestinal metaplasia, gastric intraepithelial neoplasia, gastric carcinoma
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal laser endomicroscopy (Pentax, EG3870K)Device
Confocal laser endomicroscopy with Targeted Biopsy
Standard White-light endoscopy (Pentax, 90i)Device
Standard White-light endoscopy with Standard Biopsy
| Study group | Role | What they receive |
|---|---|---|
| CLE-TB | Experimental | Confocal laser endomicroscopy with Targeted Biopsy Receives: Device: Confocal laser endomicroscopy (Pentax, EG3870K) |
| WLE-SB | Experimental | Standard White-light endoscopy with Standard Biopsy Receives: Device: Standard White-light endoscopy (Pentax, 90i) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participant with gastric IM/IN/CA
To determine whether CLE with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.
Measured: 1 year
Secondary outcomes (1)
number of biopsies needed per patient
To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/CA without the loss of corresponding diagnostic yield.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, National University Hospital, Singapore, The University of New South Wales
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642797
- Sponsor's protocol ID
- 20120621
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2012
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma: A Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01642797
- Acronym / sponsor ID
- 20120621
- Keywords
- confocal laser endomicroscopy, gastric intestinal metaplasia, gastric intraepithelial neoplasia, gastric carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, National University Hospital, Singapore, The University of New South Wales
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 17 Jul 2012 (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.
- To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol. ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield. iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.
Detailed description
Gastric cancer remains the world's second leading cause of cancer-related deaths. The prognosis for patients with this cancer clearly depends on stage at diagnosis. At least for the intestinal subtype of gastric adenocarcinoma, a cascade of histopathologic lesions has been defined: chronic gastritis, atrophic chronic gastritis, intestinal metaplasia (IM), and intraepithelial neoplasia (IN). The identification of these lesions and follow-up of patients in whom they are found could lead to diagnosis of gastric cancer at an early stage, thus improving patients' survival. The diagnosis of these lesions, which often appear in flat mucosa, is currently based on histopathologic examination of endoscopic biopsy specimens. However, conventional white-light endoscopy (WLE) for this purpose has high interobserver variability and a poor correlation with histopathologic finding.
Confocal laser endomicroscopy (CLE), producing both conventional WLE and confocal microscopic images, can provide a direct histological observation of the in vivo tissue without the need for biopsy. Recently, CLE has shown its value for diagnosing gastric IM, intraepithelial neoplasia and carcinoma. However, none of those CLE criteria for gastric IM, IN or carcinoma (CA) has been validated in various endoscopic centers, hence reducing the reliability and clinical application of them.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLE-TB | Experimental | Device: Confocal laser endomicroscopy (Pentax, EG3870K)Confocal laser endomicroscopy with Targeted Biopsy |
| WLE-SB | Experimental | Device: Standard White-light endoscopy (Pentax, 90i)Standard White-light endoscopy with Standard Biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or Female aged 18-80
- Patients with H. pylori infection, or histologically verified gastric intestinal metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis
Key exclusion criteria (3 listed)
- Patients with gastrectomy, acute GI bleeding, and advanced gastric cancer
- Patients under conditions unsuitable for performing CLE including coagulopathy, impaired renal function, pregnancy or breastfeeding, and known allergy to fluorescein sodium
- Inability to provide informed consent and other situations that could interfere with the examination protocol
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 |
|---|---|---|
| Confocal laser endomicroscopy (Pentax, EG3870K)Confocal laser endomicroscopy with Targeted Biopsy | Device | CLE-TB |
| Standard White-light endoscopy (Pentax, 90i)Standard White-light endoscopy with Standard Biopsy | Device | WLE-SB |
Primary outcome
number of participant with gastric IM/IN/CA
Time frame: 1 year
To determine whether CLE with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.
1 secondary outcome
number of biopsies needed per patient
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
Related trials for Gastric Intestinal Metaplasia
Not yet recruitingObservational study
Multi-center Prospective Validation of Real-Time AI-EGGIM System
Gastric Intestinal Metaplasia
Not yet recruitingPhase 2
Use of Pyrvinium to Reverse Stomach Precancerous Conditions
STOMACH NEOPLASM
RecruitingObservational study
Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study
Helicobacter Pylori, Atrophic Gastritis
RecruitingObservational study
Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis
Gastric Cancer, Intestinal Metaplasia
Active, not recruitingPhase 2
Curcumin in Preventing Gastric Cancer in Patients With Chronic Atrophic Gastritis or Gastric Intestinal Metaplasia
Chronic Atrophic Gastritis, Gastric Carcinoma
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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Confocal laser endomicroscopy (Pentax, EG3870K) and Standard White-light endoscopy (Pentax, 90i) in people with Gastric Intestinal Metaplasia and Gastric Intraepithelial Neoplasia, run by Shandong University at 4 sites in 3 countries.
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 3 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 18 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 4 sites in China, Australia, Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, PhD. MD. (86-531-8216923 ext. 82169508, qiluliyanqign@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participant with gastric IM/IN/CA (time frame: 1 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 18 Jul 2012.