NCT01024621

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

7 months

First QC Date

December 2, 2009

Last Update Submit

July 16, 2012

Conditions

Intestinal Metaplasia

Keywords

gastric intestinal metaplasiaConfocal laser endomicroscopy

Outcome Measures

Primary Outcomes (1)

  • the diagnostic yield of gastric intestinal metaplasia

    Seven months

Secondary Outcomes (1)

  • the biopsy number needed in each group

    Seven months

Study Arms (2)

1

EXPERIMENTAL

confocal laser endomicroscopy

Device: Endomicroscope

2

ACTIVE COMPARATOR

standard endoscopy

Device: Standard endoscopy

Interventions

EndomicroscopeDEVICE

Pentax EC3870K, Tokyo, Japan

Also known as: Pentax EC3870K endomicroscope
1
Standard endoscopyDEVICE

Pentax EG-2931 gastroscope

Also known as: Pentax EC2931 gastroscope (Pentax, Tokyo, Japan)
2

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Study Officials

  • Yanqing Li, PhD. MD.

    Department of Gastroenterology, Qilu Hospital, Shandong University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Department of Gastroenterolgoy, Qilu Hospital

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

CN(1)