Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy

Not Applicable

Completed

• Conditions: Stomach Neoplasms; Precancerous Conditions
• Interventions: Device: Endomicroscope (Pentax, Tokyo, Japan); Device: Gastroscopes (Pentax, Tokyo, Japan)

• Registration Number: NCT00851305
• Lead Sponsor: Shandong University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1786

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 confocal laser endomicroscopy	Endomicroscope (Pentax, Tokyo, Japan)	Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy.
2 Conventional endoscopy	Gastroscopes (Pentax, Tokyo, Japan)	Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy.

Primary Outcome Measures

Name	Time	Method
To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy.	one year

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs.	one year

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China