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

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ClinicalTrials.gov Identifier: NCT01024621
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, Shandong University

Brief Summary:
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 or disease Intervention/treatment Phase
Intestinal Metaplasia Device: Endomicroscope Device: Standard endoscopy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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)




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

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


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms:
Metaplasia
Pathologic Processes