Detection of Early Gastric Cancers Using Confocal Laser Endomicroscopy (CLE)

Shandong University

Status: Completed

Conditions: Precancerous Conditions; Stomach Neoplasms

Treatments: Device: Gastroscopes (Pentax, Tokyo, Japan); Device: Endomicroscope (Pentax, Tokyo, Japan)

Study type: Interventional

Funder types: Other

Identifiers

NCT00851305

2008SDU-QILU-G01

2007(Ministry of Health)

2006GG3202022

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,786 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,786 participants in 2 patient groups

1 confocal laser endomicroscopy

Experimental group

Description:

Targeted biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by confocal laser endomicroscopy.

Treatment:

Device: Endomicroscope (Pentax, Tokyo, Japan)

2 Conventional endoscopy

Active Comparator group

Description:

Routine biopsies are performed when the lesion was considered as IM, dysplasia or carcinoma by conventional endoscopy.

Treatment:

Device: Gastroscopes (Pentax, Tokyo, Japan)