Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

Shandong University1,786 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,786

Conditions

Stomach Neoplasms Precancerous Conditions

Interventions

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.

Gastroscopes (Pentax, Tokyo, Japan)DEVICE

Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

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

Time frame: one year

Secondary Outcomes

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

Time frame: one year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.