CClinicalTrials.gg
Status unknownNCT01156064Updated Nov 23, 2010

Confocal Laser Endomicroscopy in Digestive Diseases

An observational study in Digestive System Diseases, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-23.

Sponsored by Chinese PLA General Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Digestive System Diseases

Keywords

  • Endoscopy
  • Confocal laser endomicroscopy
  • Digestive Diseases
03

In context

Digestive System Diseases

613 studies on the registry are indexed under Digestive System Diseases; 117 are open to participants now.

This study's planned enrollment of 500 is above the median of 272 across 193 observational studies indexed under Digestive System Diseases.

Browse Digestive System Diseases studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients of a tertiary referral hospital

Inclusion criteria

  • Subjects over 18 years of age
  • Subjects undergoing endoscopic procedures such as gastroscopy, colonoscopy, endoscopic retrograde cholangiopancreatography and endoscopic ultrasound will all be included

Exclusion criteria

Exclusion Criteria:

  • 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,
  • Cognitively impaired.
  • Residing in institutions (eg. prison, extended care facility)
  • Have language barriers (eg. illiterate, dysphasic)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Case (subjects with digestive diseases)

    The investigators cases are subjects with confirmed digestive diseases.

    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.

    Device: Confocal Laser Endomicroscopy (Pentax/Optiscan) · Device: Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)

Interventions

  • DeviceConfocal Laser Endomicroscopy (Pentax/Optiscan)

    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.

    Also known as: Confocal endomicroscopy

  • DeviceNarrow Band Imaging/Auto Fluorescence Imaging (Olympus)

    NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.

    Also known as: Narrow Band Imaging(NBI), Auto Fluorescence Imaging(AFI)

06

What researchers measure

Primary outcomes

  1. Diagnostic yield for neoplasia of CLE vs. standard endoscopy

    Time frame: one year

Secondary outcomes

  1. Diagnostic yield for neoplasia of CLE vs. NBI/AFI

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • China PLA General Hospital
    Beijing, Bejing 100853, China
    • Jin Huang, MD · Contact · lily712@vip.sina.com
    • Yunsheng Yang, MD · Principal investigator
    • Jin Huang, MD · Sub investigator
    Recruiting
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01156064
Lead sponsor
Chinese PLA General Hospital
First posted
Jul 2, 2010
Start date
Aug 2008
Primary completion
Dec 2009 (estimated)
Completion
Dec 2011 (estimated)
Last update
Nov 23, 2010

Study contacts

YunSheng Yang, MD
Contact
sunny888@medmail.com.cn
86-10-66939747
Yunsheng Yang, MD
study chair · Chinese PLA General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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