I-scan With Magnification for the Detection of Gastric Intestinal Metaplasia
I-scan With Magnification Targeted Biopsies Compared With a Standard Biopsy Protocol for the Detection of Gastric Intestinal Metaplasia in a High Risk Population: a Randomized Controlled Trial
1 other identifier
interventional
164
1 country
1
Brief Summary
The purpose of this study is to assess whether i-scan with magnification can reduce the biopsy number needed per patient for the detection of gastric intestinal metaplasia without the loss of corresponding diagnostic yield.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 30, 2015
CompletedFirst Posted
Study publicly available on registry
August 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedAugust 6, 2015
August 1, 2015
6 months
July 30, 2015
August 3, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Difference of the detection rate of gastric intestinal metaplasia between i-scan with magnification targeted biopsies and standard endoscopy with standard biopsy protocol in a per-pateint analysis
seven months
Difference of the detection rate of gastric intestinal metaplasia between i-scan with magnification targeted biopsies and standard endoscopy with standard biopsy protocol in a per-biopsy analysis
seven months
Secondary Outcomes (1)
Number of biopsies needed in per group
seven months
Study Arms (2)
Group 1
EXPERIMENTALI-scan with magnification targeted biopsies for gastric intestinal metapalsia.
Group 2
ACTIVE COMPARATORStandard endoscopy with a standard biopsy protocol from the five standard biopsy sites following the updated Sydney System including two from the distal antrum (within 2-3cm from the pylorus, greater/lesser curvature), one from the incisura and two from the mid corpus (greater/lesser curvature).
Interventions
Eligibility Criteria
You may qualify if:
- patients with dyspeptic symptoms and aged 40 years or older
- or patients with Helicobacter pylori infection, or histologically verified gastric intestinal metaplasia or atrophic gastritis
- or patients with family history of gastric cancer
You may not qualify if:
- presence of gastrectomy, acute gastrointestinal bleeding, or known gastric neoplasia
- presence of conditions unsuitable for endoscopy procedure including coagulopathy, impaired cardiopulmonary function , pregnancy or breastfeeding
- inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Study Officials
- STUDY DIRECTOR
Yanqing Li, PhD. MD.
Department of Gastroenterology, Qilu Hospital, Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Qilu Hospital
Study Record Dates
First Submitted
July 30, 2015
First Posted
August 6, 2015
Study Start
May 1, 2015
Primary Completion
November 1, 2015
Last Updated
August 6, 2015
Record last verified: 2015-08