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Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University
ClinicalTrials.gov Identifier:
NCT01024621
First received: December 2, 2009
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.


Condition Intervention
Intestinal Metaplasia
 Device: Endomicroscope
Device: Standard endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Comparison of Confocal Laser Endomicroscopy With Standard Endoscopy for the Detection and Evaluation of Gastric Intestinal Metaplasia in a High Risk Population: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Shandong University:

Primary Outcome Measures:
  • the diagnostic yield of gastric intestinal metaplasia [ Time Frame: Seven months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the biopsy number needed in each group [ Time Frame: Seven months ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
confocal laser endomicroscopy
 Device: Endomicroscope
Pentax EC3870K, Tokyo, Japan
Other Name: Pentax EC3870K endomicroscope
Active Comparator: 2
standard endoscopy
 Device: Standard endoscopy
Pentax EG-2931 gastroscope
Other Name: Pentax EC2931 gastroscope (Pentax, Tokyo, Japan)

Detailed Description:

Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 years old ≤ age < 80 years old
  • Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia
  • Able to give informed consent.

Exclusion Criteria:

  • Esophageal, gastric or duodenal cancer or other malignancy
  • Known GIM or intraepithelial neoplasia in upper GI tract
  • Scheduled for endoscopic therapy
  • History of upper GI tract surgery
  • Reflux esophagitis or acute gastritis or peptic ulcers
  • Acute upper gastrointestinal bleeding
  • Coagulopathy or bleeding disorders
  • Allergy to fluorescein sodium
  • Pregnant or breast-feeding (for females)
  • Impaired renal function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024621

Locations
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
Investigators
Study Director: Yanqing Li, PhD. MD. Department of Gastroenterology, Qilu Hospital, Shandong University
  More Information

No publications provided

Responsible Party: Yanqing Li, Chief of the Department of Gastroenterolgoy, Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT01024621     History of Changes
Other Study ID Numbers: 2009SDU-QILU-G06
Study First Received: December 2, 2009
Last Updated: July 16, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shandong University:
gastric intestinal metaplasia
Confocal laser endomicroscopy

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

ClinicalTrials.gov processed this record on May 23, 2013