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

NCT01489397 | Completed

• 1 other identifier: RP002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Intestinal Metaplasia

Keywords

Confocol laser endomicroscopy; Feasibility of Confocol laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

• The feasibility of confocal endomicroscope in diagnose gastric intestinal metaplasia

  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.

  Up to 2 years

Study Arms (2)

Gastric intestinal metaplasia

EXPERIMENTAL

Device: Confocol laser endomicroscopy

Normal

PLACEBO COMPARATOR

Device: Confocol laser endomicroscopy

Interventions

Confocol laser endomicroscopy DEVICE

Confocal laser endomicroscopy was applied at suspected lesion and normal mucosa followed by biopsy for pathology.

Gastric intestinal metaplasia; Normal

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous gastric surgery including gastrectomy and bypass surgery
• Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
• Pregnanacy
• History of fluorescein allergy

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

Rapat Pittayanon

Bangkok, Bangkok, 10330, Thailand

Location

Related Publications (1)

• Pittayanon R, Rerknimitr R, Wisedopas N, Ridtitid W, Kongkam P, Treeprasertsuk S, Angsuwatcharakon P, Mahachai V, Kullavanijaya P. Flexible spectral imaging color enhancement plus probe-based confocal laser endomicroscopy for gastric intestinal metaplasia detection. J Gastroenterol Hepatol. 2013 Jun;28(6):1004-9. doi: 10.1111/jgh.12185.

  PMID: 23432088 DERIVED

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: December 9, 2011
• Study Start: April 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: June 11, 2014

Record last verified: 2014-06

Locations

TH (1)