Detection of Minimal Change Esophagitis by I-scan

NCT ID: NCT01560910

Last Updated: 2012-03-22

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

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

Brief Summary

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

Study design and objective The primary outcome of this prospective cohort study was to identify the endoscopic findings that have diagnostic value for the prediction of NERD (minimal change esophagitis) by using HD endoscopy with i-scan. The secondary outcome was to evaluate the response to proton pump inhibitor (PPI) in GERD patients with or without minimal change esophagitis.

Detailed Description

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

Background and aims Majority of patients with gastro-esophageal reflux disease (GERD) were non-erosive reflux disease (NERD). High definition (HD) endoscopy with i-scan could enhance visualization of mucosal and vascular pattern and might identify changes that were invisible at standard endoscopy. This study aimed to evaluate the endoscopic findings that may have diagnostic value for the prediction of NERD by using HD endoscopy with i-scan.

Methods Patients with typical GERD symptoms and healthy control without GERD symptoms were included and 2 validated GERD questionnaires were completed. The endoscopist was blinded to the presence of reflux symptoms and distal esophagus was examined using standard white light endoscopy followed by i-scan. Mucosal morphology at squamocolumnar junction (SCJ) observed by i-scan were compared between GERD patients and controls.

Conditions

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

Gastro-esophageal Reflux Disease Non-erosive Reflux Disease

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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

Inclusion Criteria

18 to 80 years of age and had ability to provide written informed consent

Exclusion Criteria

1. pregnancy,
2. cirrhosis or presence of gastroesophageal varices,
3. gastrointestinal hemorrhage,
4. angina pectoris,
5. allergy to PPI,
6. high risk or contraindication for endoscopy,
7. chronic cough,laryngitis, asthma.
Minimum Eligible Age

18 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.

arpa pungrasamee

OTHER

Sponsor Role lead

Responsible Party

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

arpa pungrasamee

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, , Thailand

Site Status

Countries

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

Thailand

Other Identifiers

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

ISSNEXI0018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Epithelial Damage in GERD
NCT01867931 COMPLETED
Barrett's Esophagus in Patients with GERD
NCT06897540 NOT_YET_RECRUITING NA