NCT01617876

Brief Summary

When performing screening endoscopy, small focal gastric lesions are frequently encountered. Novel techniques in endoscopy, such as magnifying endoscopy (ME) with narrow-band imaging (NBI) and chromoendoscopy with acetic acid-indigocarmine mixture (AIM), are developing to enhance images of gastrointestinal tumor. Furthermore, observation of the microstructures of gastric mucosa by ME, including microvascular pattern and microsurface pattern, has been proposed in the recognition of early gastric cancer (EGC). This study is based on the hypothesis as follow:

  1. 1.The microvascular structure could be clearly observed with magnifying endoscopy enhanced by narrow-band imaging (ME-NBI).
  2. 2.The microsurface architecture could be clearly observed with magnifying endoscopy enhanced by acetic acid-indigocarmine mixture (ME-AIM).
  3. 3.Enhanced ME (combining ME-NBI and ME-AIM), as compared to white-light endoscopy (WLE), has higher sensitivity and specificity for the differential diagnosing small focal gastric lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

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

March 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

June 9, 2012

Last Update Submit

June 9, 2012

Conditions

Stomach Neoplasms

Keywords

Stomach Neoplasmsearly gastric cancermagnifying endoscopynarrow band imagingacetic acidindigocarmine

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of enhanced ME (combining ME-NBI and ME-AIM)

    Enhanced ME diagnosis was made subsequent to endoscopy procedure and reviewed in a week when confirmed histopathologic diagnosis was out for comparison. Percentage of sensitivity, specificity, positive predictive value and negative predictive value of enhanced ME diagnosis compared with histopathology diagnosis were measured.

    1 week

Secondary Outcomes (3)

  • Diagnostic accuracy of WLE

    1 week

  • The relationships between the microvascular patterns and the histopathological findings

    1 week

  • The relationships between the microsurface patterns and the histopathological findings

    1 week

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who received surveillance endoscopy for EGC using a zoom endoscope were eligible for inclusion.

You may qualify if:

  • Patients, in which small focal gastric lesions were identified with conventional WLE, were enrolled in this study. Before being enrolled, all patients provided written informed consent.

You may not qualify if:

  • Patients who cannot undergo gastroscopies due to unsuitable conditions
  • Referred patients with a history of having being diagnosed as gastric cancer
  • Patients with a personal history of gastric surgery
  • Patients who cannot provide informed consent
  • Patients with advanced gastric cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Peking Union Medical College Hospital

Beijing, 100730, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy of gastric lesions

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Xinghua Lu, Dr

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Beijing Institute of Digestive Endoscopy of Chinese Medical Association

Study Record Dates

First Submitted

June 9, 2012

First Posted

June 12, 2012

Study Start

March 1, 2010

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

CN(1)