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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Diagnostic Efficacy of Narrow Band Imaging (NBI) in Patients With Gastroesophageal Reflux Disease (GERD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886197
• Other study ID #: 200707042R
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: April 21, 2009
• Start date: September 2007
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Description:

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).1 Not all of them demonstrate a favorable response to PPI treatment because the pathogenesis of NERD is in part associated with psychosomatic pathways.2 Their therapeutic response to PPI is unpredictable. Therefore, how to improve the diagnosis of reflux-induced mucosal damage under endoscopy is a worthwhile endeavor.

Minimal change esophagitis is commonly accepted as part of the spectrum of reflux esophagitis in Japan.3,4 This category is defined as "erythema without sharp demarcation, whitish turbidity, and/or invisibility of vessels due to these findings".3 Although the minimal change disease (MCD) can be recognized in a significant number of patients with reflux using endoscopy-first policy, the major drawback of this category from the Los Angeles system is due to a poor interobserver agreement (κ statistic = 0.2).

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.5 This system is highly applicable in the detection of early-stage mucosal lesions, including oral cancer, Barrett's esophagus, gastric cancer, and colonic neoplasm.6-10 For the reflux patients we face on a daily basis, the NBI system has been proven to improve the intraobserver and interobserver reproducibilities in grading esophagitis with small erosive foci (improving overall κ value to 0.62 versus 0.45).11 Corresponding to the crowding of capillaries, inflamed mucosal breaks appear dark brown on NBI, which produces intense contrast against the normal squamous epithelium and the stomach mucosa. These properties may improve our ability to delineate the margins of small inflammatory foci. Based on this advantage, we plausibly hypothesize the use of this system may improve the description of MCD and enable the prediction of therapeutic response to PPI. Testing this hypothesis is the main goal of our study.

Aim of the Study To assess the clinical utility and therapeutic implications of NBI in evaluating reflux patients with minimal mucosal damage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

1. Symptomatic reflux patients with apparent erosive esophagitis in conventional endoscopy.

2. Symptomatic reflux patients with a history of using PPI in recent 4 months.

3. Subjects with known allergy to PPI.

4. Peptic ulcer disease

5. Cancers of the esophagus, stomach, and duodenum

6. Esophageal varices.

7. Active upper gastrointestinal bleeding within 7 days prior to enrollment

8. Status after total or subtotal gastrectomy

9. Use of anticoagulants or antiplatelets within one week prior to enrollment

10. Subjects with bleeding tendency

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic response to proton-pump inhibitor (PPI)		14 days	No