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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01642797




Registration number
NCT01642797
Ethics application status
Date submitted
11/07/2012
Date registered
17/07/2012
Date last updated
18/07/2012

Titles & IDs
Public title
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma
Scientific title
Confocal Laser Endomicroscopy for the Diagnosis of Gastric Intestinal Metaplasia, Intraepithelial Neoplasia, and Carcinoma: A Multicenter, Randomized, Controlled Trial
Secondary ID [1] 0 0
20120621
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Intestinal Metaplasia 0 0
Gastric Intraepithelial Neoplasia 0 0
Gastric Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Cervical (cervix)
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Stomach
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Confocal laser endomicroscopy (Pentax, EG3870K)
Treatment: Devices - Standard White-light endoscopy (Pentax, 90i)

Experimental: CLE-TB - Confocal laser endomicroscopy with Targeted Biopsy

Experimental: WLE-SB - Standard White-light endoscopy with Standard Biopsy


Treatment: Devices: Confocal laser endomicroscopy (Pentax, EG3870K)
Confocal laser endomicroscopy with Targeted Biopsy

Treatment: Devices: Standard White-light endoscopy (Pentax, 90i)
Standard White-light endoscopy with Standard Biopsy
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
number of participant with gastric IM/IN/CA
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
number of biopsies needed per patient
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
- Male or Female aged 18-80

- Patients with H. pylori infection, or histologically verified gastric intestinal
metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2013
Actual
Sample size
Target
242
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
the University of New South Wales, Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 0 0
- Bankstown
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hongkong
Country [2] 0 0
China
State/province [2] 0 0
Shandong
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Shandong University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Prince of Wales Hospital, Shatin, Hong Kong
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National University Hospital, Singapore
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
The University of New South Wales
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01642797
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yanqing Li, PhD. MD.
Address 0 0
Country 0 0
Phone 0 0
86-531-8216923
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01642797