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Completed

NCT Number: NCT00851305

Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

The purpose of this study is to determine whether endomicroscopy can improve the detection of Early Gastric Cancers (EGC).

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Precancerous Conditions Stomach Diseases

Age range

45 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

Endoscopy is proved to be the best method to achieve early diagnosis of gastric cancer (GC). Confocal laser endomicroscopy (CLE), a new diagnostic modality, has been shown to be valuable in increasing the diagnostic yield of colorectal neoplasias, but it is not clear whether CLE is helpful to find out early gastric cancer (EGC).The aim of the study is to investigate the value of CLE in improving the detection of EGCs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 45 years old ≤ age < 80 years old
  • Patients with dyspeptic symptoms or with gastric premalignant conditions for surveillance gastroscopy

Exclusion criteria

  • Known cancers or gastrectomy
  • Scheduled for endoscopic treatment
  • Alarm symptoms such as dysphagia, anaemia, gastrointestinal bleeding or obstruction, marked weight loss
  • Under conditions such as:
  • ascites
  • jaundice
  • liver cirrhosis
  • impaired renal function
  • coagulopathy
  • fever
  • pregnancy
  • breastfeeding
  • Inability to provide informed consent
  • Known allergy to fluorescein sodium

Treatment and study plan

Endomicroscope (Pentax, Tokyo, Japan)

Device

A Pentax EC3870K endomicroscope which can produce conventional white light endoscopic images and confocal images at the same time with a optical slice thickness of 7 μm, a lateral resolution of 0.7 μm, a scanning depth of 0 to 250 μm, a pixel density of 1024×512 pixels (at an image acquisition rate of 1.6 frames/second)，and a field of view of 475 μm×475 μm.

Other names: Pentax EC3870K endomicroscope

Gastroscopes (Pentax, Tokyo, Japan)

Device

Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)

Other names: Pentax EG-2940 gastroscopes (Pentax, Tokyo, Japan)

Primary outcomes

  1. To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.

    Time frame: one year

Secondary outcomes

  1. To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Comparison Confocal Laser Endomicroscopy With Conventional Endoscopy for the Detection of Early Gastric Cancers

Acronym: CLE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 25, 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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