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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00851305
Other study ID # 2008SDU-QILU-G01
Secondary ID 2006GG3202022200
Status Completed
Phase N/A
First received February 24, 2009
Last updated July 16, 2012
Start date August 2008
Est. completion date July 2009

Study information

Verified date July 2012
Source Shandong University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 1786
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
Endomicroscope (Pentax, Tokyo, Japan)
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)
Conventional white light gastroscopes (Pentax EG-2940 gastroscopes)

Locations

Country Name City State
China Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong

Sponsors (1)

Lead Sponsor Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the rate of EGCs/GCs using CLE versus conventional gastroscopy. one year No
Secondary To evaluate the efficacy of in vivo CLE on different pathological characteristics of EGCs. one year No
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