Diagnostic Yield of Gastric NeoplasiaPCLENCT02515721
PCLE for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma
A study testing pCLE-TB and virtual chromoendoscopy-TB in people with Diagnostic Yield of Gastric Neoplasia, run by Shandong University at 1 site in China.
Trial summary
Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and gastric cancer are essential to improve patients' outcomes. This study aims to compare the diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based confocal laser endomicroscopy (pCLE) and iScan… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diagnostic Yield of Gastric Neoplasia
- What is being tested?
- pCLE-TB and virtual chromoendoscopy-TB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Aug 2015
- 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
- aged between 18 and 80;
- patients with previous pathologic diagnosis of atrophic gastritis, gastric intestinal metaplasia, and low-grade intraepithelial neoplasia;
- agree to give written informed consent.
Who cannot join
- Patients with gastrectomy, acute GI bleeding, and known gastric neoplasia;
- Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), impaired renal function (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Endoscopic unit of Qilu Hospital Shandong University
Jinan, Shandong, 250001
Li Yanqing, PhD, MD, 053182169385, liyanqing@sdu.edu.cn
Li Zhen, PhD, MD, 18560086106, lizhenh@hotmail.com
About this study
Official title: Probe-based Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia,Intraepithelial Neoplasia,and Carcinoma:A Multicenter,Randomized,Controlled Trial
Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and gastric cancer are essential to improve patients' outcomes. This study aims to compare the diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based confocal laser endomicroscopy (pCLE) and iScan alone.
- Conditions
- Diagnostic Yield of Gastric Neoplasia
- Being tested
- pCLE-TB, virtual chromoendoscopy-TB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pCLE-TBDevice
Also called probe-based confocal laser endomicroscopy with targeted biopsies
Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.
virtual chromoendoscopy-TBDevice
Also called virtual chromoendoscopy with targeted biopsies
Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.
| Study group | Role | What they receive |
|---|---|---|
| pCLE-TB | Experimental | Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma. Receives: Device: pCLE-TB |
| Virtual Chromoendoscopy -SB | Experimental | Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions. Receives: Device: virtual chromoendoscopy-TB |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer
Measured: 12 months
Secondary outcomes (1)
the biopsy number needed for diagnosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startJul 2014
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diagnostic Yield of Gastric NeoplasiaStudies 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
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Zhejiang University
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515721
- Sponsor's protocol ID
- 2015SDU-QILU-G06
- Acronym
- PCLE
- Status last verified
- Aug 2015
- First submitted
- 3 Aug 2015
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zuo XL, Li Z, Li CQ, Zheng YY, Xu LD, Chen J, Lin R, Song J, Yu CH, Yue M, Zhou Q, Liu ZY, Li YQ. Probe-based endomicroscopy for in vivo detection of gastric intestinal metaplasia and neoplasia: a multicenter randomized controlled trial. Endoscopy. 2017 Nov;49(11):1033-1042. doi: 10.1055/s-0043-115382. Epub 2017 Jul 28.
PubMed 28753702
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probe-based Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia,Intraepithelial Neoplasia,and Carcinoma:A Multicenter,Randomized,Controlled Trial
- ClinicalTrials.gov ID
- NCT02515721
- Acronym / sponsor ID
- PCLE / 2015SDU-QILU-G06
- Conditions
- Diagnostic Yield of Gastric Neoplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Zhejiang University
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (estimated)
- First posted
- 5 Aug 2015 (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.
Early detection of gastric intestinal metaplasia (GIM) intraepithelial neoplasia (IN), and gastric cancer are essential to improve patients' outcomes. This study aims to compare the diagnostic yield of GIM, IN and early gastric cancer (EGC) by iScan combined probe-based confocal laser endomicroscopy (pCLE) and iScan alone.
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 |
|---|---|---|
| pCLE-TB | Experimental | Device: pCLE-TBPatients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma. |
| Virtual Chromoendoscopy -SB | Experimental | Device: virtual chromoendoscopy-TBPatients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between 18 and 80;
- patients with previous pathologic diagnosis of atrophic gastritis, gastric intestinal metaplasia, and low-grade intraepithelial neoplasia;
- agree to give written informed consent.
Key exclusion criteria (3 listed)
- Patients with gastrectomy, acute GI bleeding, and known gastric neoplasia;
- Patients under conditions unsuitable for performing CLE including coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 s), impaired renal function (creatinine level >1.2 mg/dL), pregnancy or breastfeeding, and known allergy to fluorescein sodium;
- 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 |
|---|---|---|
| pCLE-TBAlso: probe-based confocal laser endomicroscopy with targeted biopsiesPatients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma. | Device | pCLE-TB |
| virtual chromoendoscopy-TBAlso: virtual chromoendoscopy with targeted biopsiesPatients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions. | Device | Virtual Chromoendoscopy -SB |
Primary outcome
the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer
Time frame: 12 months
1 secondary outcome
the biopsy number needed for diagnosis
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
- Derived from this study: PubMed 28753702Zuo XL, Li Z, Li CQ, Zheng YY, Xu LD, Chen J, Lin R, Song J, Yu CH, Yue M, Zhou Q, Liu ZY, Li YQ. Probe-based endomicroscopy for in vivo detection of gastric intestinal metaplasia and neoplasia: a multicenter randomized controlled trial. Endoscopy. 2017 Nov;49(11):1033-1042. doi: 10.1055/s-0043-115382. Epub 2017 Jul 28.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pCLE-TB and virtual chromoendoscopy-TB in people with Diagnostic Yield of Gastric Neoplasia, 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 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 5 Aug 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yanqing, PhD, MD (053182169385, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnostic yield of intestinal metaplasia, intraepithelial neoplasia, and gastric cancer (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515721, which also lists 1 linked publication.
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 5 Aug 2015.