NCT01642797

Brief Summary

i. To determine whether Confocal Laser Endomicroscopy (CLE) with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol. ii. To determine whether CLE with optical biopsy and targeted biopsy, as compared to WLE with standard biopsy, can reduce the number of biopsies needed per patient for detection of gastric IM/IN/carcinoma without the loss of corresponding diagnostic yield. iii. To compare the sensitivity and specificity of CLE with WLE for the detection of gastric IM/IN/CA.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
3 countries

4 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

July 11, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

July 11, 2012

Last Update Submit

July 17, 2012

Conditions

Gastric Intestinal MetaplasiaGastric Intraepithelial NeoplasiaGastric Carcinoma

Keywords

confocal laser endomicroscopygastric intestinal metaplasiagastric intraepithelial neoplasiagastric carcinoma

Outcome Measures

Primary Outcomes (1)

  • number of participant with gastric IM/IN/CA

    To determine whether CLE with optical biopsy and targeted mucosal biopsy improves the diagnostic yield of gastric IM/IN/CA in high risk populations compared to WLE with standard biopsy protocol.

    1 year

Secondary Outcomes (1)

  • number of biopsies needed per patient

    1 year

Study Arms (2)

CLE-TB

EXPERIMENTAL

Confocal laser endomicroscopy with Targeted Biopsy

Device: Confocal laser endomicroscopy (Pentax, EG3870K)

WLE-SB

EXPERIMENTAL

Standard White-light endoscopy with Standard Biopsy

Device: Standard White-light endoscopy (Pentax, 90i)

Interventions

Confocal laser endomicroscopy (Pentax, EG3870K)DEVICE

Confocal laser endomicroscopy with Targeted Biopsy

CLE-TB
Standard White-light endoscopy (Pentax, 90i)DEVICE

Standard White-light endoscopy with Standard Biopsy

WLE-SB

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female aged 18-80
  • Patients with H. pylori infection, or histologically verified gastric intestinal metaplasia, low-grade intraepithelial neoplasia, and atrophic gastritis

You may not qualify if:

  • Patients with gastrectomy, acute GI bleeding, and advanced gastric cancer
  • Patients under conditions unsuitable for performing CLE including coagulopathy, impaired renal function, pregnancy or breastfeeding, and known allergy to fluorescein sodium
  • Inability to provide informed consent and other situations that could interfere with the examination protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

the University of New South Wales, Bankstown-Lidcombe Hospital

Bankstown, Australia

Location

the Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hongkong, China

Location

Qilu Hospital, Shandong University

Jinan, Shandong, 20012, China

Location

National University Hospital, National University of Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Yanqing Li, PhD. MD.

CONTACT

86-531-8216923qiluliyanqign@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the department of Gastroenterology

Study Record Dates

First Submitted

July 11, 2012

First Posted

July 17, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

SG(1)CN(2)AU(1)