MedDataX Logo

Confocal Laser Endomicroscopy for the Detection of Gastric Intestinal Metaplasia: a Randomized Controlled Trial

NCT ID: NCT01024621

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess whether confocal laser endomicroscopy can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Gastric intestinal metaplasia is a well-known premalignant lesions for intestinal type gastric cancer. However, present guidelines such as the updated Sydney System require multiple biopsies whereas reveal an unsatisfactory yield considering the detection and surveillance of these lesions. Confocal laser endomicroscopy is a newly developed endoscopic device that enables microscopic view of the digestive tract. Previous study has showed high sensitivity and specificity for in vivo diagnosis of gastric intestinal metaplasia using confocal laser endomicroscopy. This study aims to assess the real number of biopsies that can be reduced for the detection of gastric intestinal metaplasia using confocal laser endomicroscopy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intestinal Metaplasia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

gastric intestinal metaplasia Confocal laser endomicroscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

confocal laser endomicroscopy

Group Type EXPERIMENTAL

Endomicroscope

Intervention Type DEVICE

Pentax EC3870K, Tokyo, Japan

2

standard endoscopy

Group Type ACTIVE_COMPARATOR

Standard endoscopy

Intervention Type DEVICE

Pentax EG-2931 gastroscope

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endomicroscope

Pentax EC3870K, Tokyo, Japan

Intervention Type DEVICE

Standard endoscopy

Pentax EG-2931 gastroscope

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pentax EC3870K endomicroscope Pentax EC2931 gastroscope (Pentax, Tokyo, Japan)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 40 years old ≤ age \< 80 years old
* Patients with dyspeptic symptoms and/or with certain risk factors of gastric intestinal metaplasia
* Able to give informed consent.

Exclusion Criteria

* Esophageal, gastric or duodenal cancer or other malignancy
* Known GIM or intraepithelial neoplasia in upper GI tract
* Scheduled for endoscopic therapy
* History of upper GI tract surgery
* Reflux esophagitis or acute gastritis or peptic ulcers
* Acute upper gastrointestinal bleeding
* Coagulopathy or bleeding disorders
* Allergy to fluorescein sodium
* Pregnant or breast-feeding (for females)
* Impaired renal function
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yanqing Li

Chief of the Department of Gastroenterolgoy, Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yanqing Li, PhD. MD.

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital, Shandong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009SDU-QILU-G06

Identifier Type: -

Identifier Source: org_study_id