Diagnostic Efficacy of Narrow Band Imaging in Patients With Gastroesophageal Reflux Disease

NCT00886197 | Completed

• 1 other identifier: 200707042R
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Gastroesophageal reflux disease (GERD) is a common disorder in Asia that includes erosive and non-erosive counterparts. The evaluation of intra-esophageal damage is of paramount importance because patients with erosive and those with non-erosive GERD have distinct manifestations and prognoses. Although proton-pump inhibitor (PPI) is the treatment of choice for erosive patients with excellent therapeutic response, the majority of reflux patients can be classified with non-erosive reflux disease (NERD).Narrow-band imaging (NBI) is a novel, noninvasive optical technique that adjusts reflected light to improve the contrast of capillary patterns compared with conventional illumination. Based on the standard procedure of sequential conventional white-light, NBI, and magnified NBI, the investigators have validated the reliability of the diagnostic testing. The investigators will also enroll NERD patients to test their therapeutic response to rabeprazole. The investigators can find out the best strategy to identify the PPI responder.

Conditions

Gastroesophageal Reflux Disease

Keywords

reflux; GERD

Outcome Measures

Primary Outcomes (1)

• Therapeutic response to proton-pump inhibitor (PPI)

  14 days

Study Arms (1)

GERD

1. Symptomatic reflux subjects who receive esophagogastroscopy, aged from 20 to 70 years old. 2. Patients with typical reflux symptoms (heartburn and/or acid regurgitation) at least 3 times per week in recent 4 months.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Symptomatic reflux subjects who receive esophagogastroscopy, aged from 20 to 70 years old. 2. Patients with typical reflux symptoms (heartburn and/or acid regurgitation) at least 3 times per week in recent 4 months.

You may qualify if:

• Symptomatic reflux subjects who receive esophagogastroscopy, aged from 20 to 70 years old.
• Patients with typical reflux symptoms (heartburn and/or acid regurgitation) at least 3 times per week in recent 4 months.

You may not qualify if:

• Symptomatic reflux patients with apparent erosive esophagitis in conventional endoscopy.
• Symptomatic reflux patients with a history of using PPI in recent 4 months.
• Subjects with known allergy to PPI.
• Peptic ulcer disease
• Cancers of the esophagus, stomach, and duodenum
• Esophageal varices.
• Active upper gastrointestinal bleeding within 7 days prior to enrollment
• Status after total or subtotal gastrectomy
• Use of anticoagulants or antiplatelets within one week prior to enrollment
• Subjects with bleeding tendency

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Yi-Chia Lee, MD,MSc

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 22, 2009
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 22, 2009

Record last verified: 2009-04

Locations

TW (1)