Digestive System DiseasesNCT01156064
Confocal Laser Endomicroscopy in Digestive Diseases
An observational study of Digestive System Diseases, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Confocal laser endomicroscopy (CLE) is a newly endoscopic device that enables microscopic view of the digestive tract. The purpose of this study is to determine if confocal laser endomicroscopy can improve detection of digestive disease include inflammation, dysplasia, and early cancer, and if confocal laser… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive System Diseases
- What is being tested?
- Confocal Laser Endomicroscopy (Pentax/Optiscan) and Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Dec 2011
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of a tertiary referral hospital
Who may be able to join
- Subjects over 18 years of age
- Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included
Who cannot join
- Under 18 years of age.
- Pregnancy or breast feeding
- Allergy to the fluorescent contrast agent fluorescein sodium
- Coagulopathy or bleeding disorder
- In emergency or life-threatening situations(eg. acute gastrointestinal hemorrhage, and gastrointestinal obstruction or perforation)
- impaired renal function, allergic asthma,
Show all 9Show fewer
- Cognitively impaired.
- Residing in institutions (eg. prison, extended care facility)
- Have language barriers (eg. illiterate, dysphasic)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China PLA General Hospital
Beijing, Bejing, 100853
Jin Huang, MD, lily712@vip.sina.com
Yunsheng Yang, MD
About this study
Confocal laser endomicroscopy (CLE) is a newly endoscopic device that enables microscopic view of the digestive tract. The purpose of this study is to determine if confocal laser endomicroscopy can improve detection of digestive disease include inflammation, dysplasia, and early cancer, and if confocal laser endomicroscopy has competitive advantage, compared with other device such as Narrow Band Imaging and Autofluoresecence Imaging.
Read the detailed description
Advances in endoscopy have led to imagining of the details of digestive mucosa. Novel techniques such as Narrow Band Imaging (NBI) assisted magnification endoscopy, Auto Fluorescence Imaging (AFI) or confocal laser endomicroscopy could, however, improve the endoscopic detection.In this research we describe the combined use of these three techniques in patients with digestive disease.
- Conditions
- Digestive System Diseases
- Being tested
- Confocal Laser Endomicroscopy (Pentax/Optiscan), Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)
- Keywords
- Endoscopy, Confocal laser endomicroscopy, Digestive Diseases
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confocal Laser Endomicroscopy (Pentax/Optiscan)Device
Also called Confocal endomicroscopy
Confocal laser endomicroscopy is performed using the Pentax/Optiscan confocal endomicroscopy and 5 ml of 10% intravenous fluorescein sodium. Photos of magnified images of the digestive mucosa are taken during the procedure.
Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)Device
Also called Narrow Band Imaging(NBI), Auto Fluorescence Imaging(AFI)
NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.
| Study group | Role | What they receive |
|---|---|---|
| Case (subjects with digestive diseases) | The investigators cases are subjects with confirmed digestive diseases. Receives: Device: Confocal Laser Endomicroscopy (Pentax/Optiscan); Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus) | |
| Control | Healthy individuals aged between 18 and 90 years who are asymptomatic for digestive diseases. Receives: Device: Confocal Laser Endomicroscopy (Pentax/Optiscan); Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield for neoplasia of CLE vs. standard endoscopy
Measured: one year
Secondary outcomes (1)
Diagnostic yield for neoplasia of CLE vs. NBI/AFI
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 posted2 Jul 2010 (estimated)
- Study startAug 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2011 (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 Digestive System DiseasesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yunsheng Yang, MD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156064
- Sponsor's protocol ID
- 07CX201
- Status last verified
- Jul 2010
- First submitted
- 29 Jun 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.
PubMed 26078575
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy in Digestive Diseases
- ClinicalTrials.gov ID
- NCT01156064
- Acronym / sponsor ID
- 07CX201
- Conditions
- Digestive System Diseases
- Keywords
- Endoscopy, Confocal laser endomicroscopy, Digestive Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 2 Jul 2010 (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.
Confocal laser endomicroscopy (CLE) is a newly endoscopic device that enables microscopic view of the digestive tract. The purpose of this study is to determine if confocal laser endomicroscopy can improve detection of digestive disease include inflammation, dysplasia, and early cancer, and if confocal laser endomicroscopy has competitive advantage, compared with other device such as Narrow Band Imaging and Autofluoresecence Imaging.
Detailed description
Advances in endoscopy have led to imagining of the details of digestive mucosa. Novel techniques such as Narrow Band Imaging (NBI) assisted magnification endoscopy, Auto Fluorescence Imaging (AFI) or confocal laser endomicroscopy could, however, improve the endoscopic detection.In this research we describe the combined use of these three techniques in patients with digestive disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case (subjects with digestive diseases) | – | Device: Confocal Laser Endomicroscopy (Pentax/Optiscan), Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)The investigators cases are subjects with confirmed digestive diseases. |
| Control | – | Device: Confocal Laser Endomicroscopy (Pentax/Optiscan), Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)Healthy individuals aged between 18 and 90 years who are asymptomatic for digestive diseases. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of a tertiary referral hospital
Key inclusion criteria (2 listed)
- Subjects over 18 years of age
- Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included
Key exclusion criteria (9 listed)
- Under 18 years of age.
- Pregnancy or breast feeding
- Allergy to the fluorescent contrast agent fluorescein sodium
- Coagulopathy or bleeding disorder
- In emergency or life-threatening situations(eg. acute gastrointestinal hemorrhage, and gastrointestinal obstruction or perforation)
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/Optiscan)Also: Confocal endomicroscopyConfocal laser endomicroscopy is performed using the Pentax/Optiscan confocal endomicroscopy and 5 ml of 10% intravenous fluorescein sodium. Photos of magnified images of the digestive mucosa are taken during the procedure. | Device | Case (subjects with digestive diseases), Control |
| Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)Also: Narrow Band Imaging(NBI), Auto Fluorescence Imaging(AFI)NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time. | Device | Case (subjects with digestive diseases), Control |
Primary outcome
Diagnostic yield for neoplasia of CLE vs. standard endoscopy
Time frame: one year
1 secondary outcome
Diagnostic yield for neoplasia of CLE vs. NBI/AFI
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
- Derived from this study: PubMed 26078575Huang J, Yang YS, Lu ZS, Wang SF, Yang J, Yuan J. Detection of superficial esophageal squamous cell neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. World J Gastroenterol. 2015 Jun 14;21(22):6974-81. doi: 10.3748/wjg.v21.i22.6974.
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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.
Yunsheng Yang, MD study chair
Chinese PLA General Hospital
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 Digestive System Diseases, run by Chinese PLA General Hospital 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 9 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 23 Nov 2010. 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 YunSheng Yang, MD (86-10-66939747, sunny888@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield for neoplasia of CLE vs. standard endoscopy (time frame: one year). 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 NCT01156064, 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 23 Nov 2010.