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Magnified Intelligence Chromoendoscopy Plus Probe-based Confocal Laser Endomicroscopy for Gastric Intestinal Metaplasia Diagnosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01489397
First received: December 5, 2011
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

Magnified intelligence chromoendoscopy (FICE) plus probe-based confocal laser endomicroscopy (pCLE) for Gastric Intestinal Metaplasia (GIM) diagnosis: a feasibility trial

Research Question:

Is confocal endomicroscope feasible to diagnose gastric intestinal metaplasia?

Objective:

To evaluate the feasibility of confocal endomicroscope in diagnose gastric intestinal metaplasia.

Hypothesis:

Confocal endomicreosocpe can provide the accurate diagnosis of gastric intestinal metaplasia.

Research design:

Diagnostic study

Sample size:

The investigators follow the population in recent study from Imraporn et al.: Validity of magnify NBI for gastric intestinal metaplasia targeted biopsy (N= 50)

Data analysis:

Confocal Barrett's esophagus classification was used to evaluate agreement of confocal endomicroscopic finding in gastric intestinal metaplasia. The accuracy of new criteria for GIM by confocal endomicroscope was evaluated in relation to pathological report, a gold standard for diagnosis, and reported as sensitivity, specificity, positive predictive value, negative predictive value and accuracy of these criteria.

Expected Benefit and Application:

The feasibility of confocal endomicroscopy for diagnosis gastric intestinal metaplasia in order to improve the quality of GIM/dysplasia/early gastric cancer detection and then decrease the mortality rate from gastric cancer in the future.


Condition Intervention
Gastric Intestinal Metaplasia
Device: Confocol laser endomicroscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Further study details as provided by King Chulalongkorn Memorial Hospital:

Primary Outcome Measures:
  • The feasibility of confocal endomicroscope in diagnose gastric intestinal metaplasia [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    If GIM can be detected properly, early gastric cancer(EGC) will be in early recognition. EGC can be cured by endoscopic resection and then the mortality rate from gastric cancer will be decrease.


Enrollment: 45
Study Start Date: April 2010
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gastric intestinal metaplasia Device: Confocol laser endomicroscopy
Confocal laser endomicroscopy was applied at suspected lesion and normal mucosa followed by biopsy for pathology.
Placebo Comparator: Normal Device: Confocol laser endomicroscopy
Confocal laser endomicroscopy was applied at suspected lesion and normal mucosa followed by biopsy for pathology.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-80 year-old
  2. All patients were diagnosed GIM in the past 2 years.
  3. All patients have to sign the consent form

Exclusion Criteria:

  1. Previous gastric surgery including gastrectomy and bypass surgery
  2. Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
  3. Pregnanacy
  4. History of fluorescein allergy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01489397

Locations
Thailand
Rapat Pittayanon
Bangkok, Thailand, 10330
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Rapat Pittayanon, MD, Principle investigator, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT01489397     History of Changes
Other Study ID Numbers: RP002
Study First Received: December 5, 2011
Last Updated: June 9, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by King Chulalongkorn Memorial Hospital:
Confocol laser endomicroscopy
Feasibility of Confocol laser endomicroscopy

Additional relevant MeSH terms:
Gastritis, Atrophic
Metaplasia
Digestive System Diseases
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Pathologic Processes
Stomach Diseases

ClinicalTrials.gov processed this record on November 25, 2014