Ignite Creation Date:
2024-05-05 @ 9:26 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00886197
Status:
COMPLETED
Last Update Posted:
2009-04-22
First Post:
2009-04-20
Brief Title:
Diagnostic Efficacy of Narrow Band Imaging in Patients With Gastroesophageal Reflux Disease
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Diagnostic Efficacy of Narrow Band Imaging NBI in Patients With Gastroesophageal Reflux Disease GERD
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 NERDNarrow-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
Detailed 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 NERD1 Not all of them demonstrate a favorable response to PPI treatment because the pathogenesis of NERD is in part associated with psychosomatic pathways2 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 Japan34 This category is defined as erythema without sharp demarcation whitish turbidity andor invisibility of vessels due to these findings3 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 02
Narrow-band imaging NBI is a novel noninvasive optical technique that adjusts reflected light to improve the contrast of capillary patterns compared with conventional illumination5 This system is highly applicable in the detection of early-stage mucosal lesions including oral cancer Barretts esophagus gastric cancer and colonic neoplasm6-10 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 062 versus 04511 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
Minimal change esophagitis is commonly accepted as part of the spectrum of reflux esophagitis in Japan34 This category is defined as erythema without sharp demarcation whitish turbidity andor invisibility of vessels due to these findings3 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 02
Narrow-band imaging NBI is a novel noninvasive optical technique that adjusts reflected light to improve the contrast of capillary patterns compared with conventional illumination5 This system is highly applicable in the detection of early-stage mucosal lesions including oral cancer Barretts esophagus gastric cancer and colonic neoplasm6-10 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 062 versus 04511 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None