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

This study has been completed.
Information provided by (Responsible Party):
Yanqing Li, Shandong University Identifier:
First received: December 2, 2009
Last updated: July 16, 2012
Last verified: July 2012
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
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
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:

Further study details as provided by Yanqing Li, Shandong University:

Primary Outcome Measures:
  • the diagnostic yield of gastric intestinal metaplasia [ Time Frame: Seven months ]

Secondary Outcome Measures:
  • the biopsy number needed in each group [ Time Frame: Seven months ]

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.

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01024621

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

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

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

Additional relevant MeSH terms:
Pathologic Processes processed this record on June 26, 2017