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Completed

NCT Number: NCT01024621

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

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.

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Key information

Conditions

Intestinal Metaplasia

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endomicroscope

Device

Pentax EC3870K, Tokyo, Japan

Other names: Pentax EC3870K endomicroscope

Standard endoscopy

Device

Pentax EG-2931 gastroscope

Other names: Pentax EC2931 gastroscope (Pentax, Tokyo, Japan)

Primary outcomes

  1. the diagnostic yield of gastric intestinal metaplasia

    Time frame: Seven months

Secondary outcomes

  1. the biopsy number needed in each group

    Time frame: Seven months

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 3, 2009
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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