Ignite Creation Date:
2024-05-06 @ 10:13 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03191604
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2017-06-15
Brief Title:
Impact of NBI on Patients Undergoing Endoscopic Eradication Therapy
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Multicenter Study Evaluating the Impact of NBI on Patients With Barretts Esophagus Associated Neoplasia Undergoing Endoscopic Eradication Therapy EET
Status:
COMPLETED
Status Verified Date:
2019-11
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:
This study tests the impact of narrow band imaging NBI on endoscopists accurate detection of visible lesions and dysplasia in patients with Barretts esophagus as well as the effect of NBI on the choice of primary treatment modality among endoscopists performing endoscopic eradication therapy EET
Detailed Description:
Barretts esophagus BE is a condition whereby normal esophageal squamous epithelium is replaced by metaplastic columnar epithelium predisposing patients to esophageal adenocarcinoma EAC It is estimated that about 56 of adults in the United States have BE with risk factors including long standing gastroesophageal reflux disease tobacco use male gender central obesity and age over 50 years EAC is believed to progress in a step-wise pattern with the following order of non-dysplastic BE low-grade dysplasia LGD and high-grade dysplasia HGD Each carries a risk of progression to EAC differing by degree of dysplasia 02-05 07 and 7 per year respectively Given this association it is common practice to perform endoscopic surveillance with biopsies in patients with BE Endoscopic surveillance has been shown to detect EAC at earlier stages and improve survival in asymptomatic presentations As dysplasia in BE may not always be seen as a distinct lesion surveillance programs entail use of the Seattle Protocol a systematic four-quadrant biopsy technique obtained at 1 to 2 cm increments Current guidelines recommend the use of high-definition white light endoscopy HD-WLE as it is superior over standard-definition in regards to improved targeted detection of dysplasia
Advanced endoscopic imaging techniques have been proposed to improve dysplasia detection with preference for electronic chromoendoscopy specifically narrow band imaging NBI as it does not require dye sprays NBI has been shown to be more accurate in detecting intestinal metaplasia and HGD HGD is more often detected in areas with subtle mucosal and vascular abnormalities which may be more difficult to see on HD-WLE alone However subtle lesions may go undetected as NBI is not routinely used in the community with a recent survey showing only about a third of practicing gastroenterologists use advanced endoscopic imaging The widespread use of NBI has been potentially limited by a perceived complexity of interpretation and lack of standardization Recently Sharma et al introduced the BING criteria - a standardized classification system to detect dysplasia and EAC with NBI While a few studies have demonstrated no significant difference in detection of dysplasia or neoplasia between HD-WLE and NBI they have had some limitations The studies occurred prior to the BING classification system and participants were limited to a few expert tertiary medical centers
The current standard of care for visible lesions identified by HD-WLE nodules ulcers erosions or plaques is endoscopic mucosal resection EMR Endoscopic recognition and appropriate resection of visible lesions is essential for optimal patient outcomes Staging EMR is critical as it allows for histopathological upgrading or downgrading of dysplasia and ultimately is the best tool for identifying and treating early EAC Despite the importance of EMR for BE-AN survey data suggests it is underutilized in practice with 39 of academic endoscopists and 13 of community-based endoscopists performing EMR While many endoscopists utilize NBI to assist in identification of visible lesions the resection of areas deemed abnormal by NBI alone is not widely accepted Moreover endoscopists at community hospitals detect neoplastic lesions at significantly lower rates than at BE expert centers
Given these data routine use of NBI prior to EET could significantly impact treatment decisions among all endoscopists with highly accurate rates of dysplasia detection Its been shown that NBI increases the accuracy and positive predictive value of predicting histology than if HD-WLE is used alone This study is limited by the use of still-images which does not accurately reproduce live images seen during endoscopy Nevertheless the current standard of using HD-WLE for identification of visible lesions likely underestimates the presence of dysplastic areas in patients undergoing Endoscopic Eradication Therapy EET for BE-AN We hypothesize that the routine use of narrow band imaging NBI for identification of visible lesions will improve dysplasia detection and have a significant effect on the choice of primary treatment modality among endoscopists performing EET To this end we propose a video-based study to evaluate the impact of NBI on choice of treatment modality during EET
Advanced endoscopic imaging techniques have been proposed to improve dysplasia detection with preference for electronic chromoendoscopy specifically narrow band imaging NBI as it does not require dye sprays NBI has been shown to be more accurate in detecting intestinal metaplasia and HGD HGD is more often detected in areas with subtle mucosal and vascular abnormalities which may be more difficult to see on HD-WLE alone However subtle lesions may go undetected as NBI is not routinely used in the community with a recent survey showing only about a third of practicing gastroenterologists use advanced endoscopic imaging The widespread use of NBI has been potentially limited by a perceived complexity of interpretation and lack of standardization Recently Sharma et al introduced the BING criteria - a standardized classification system to detect dysplasia and EAC with NBI While a few studies have demonstrated no significant difference in detection of dysplasia or neoplasia between HD-WLE and NBI they have had some limitations The studies occurred prior to the BING classification system and participants were limited to a few expert tertiary medical centers
The current standard of care for visible lesions identified by HD-WLE nodules ulcers erosions or plaques is endoscopic mucosal resection EMR Endoscopic recognition and appropriate resection of visible lesions is essential for optimal patient outcomes Staging EMR is critical as it allows for histopathological upgrading or downgrading of dysplasia and ultimately is the best tool for identifying and treating early EAC Despite the importance of EMR for BE-AN survey data suggests it is underutilized in practice with 39 of academic endoscopists and 13 of community-based endoscopists performing EMR While many endoscopists utilize NBI to assist in identification of visible lesions the resection of areas deemed abnormal by NBI alone is not widely accepted Moreover endoscopists at community hospitals detect neoplastic lesions at significantly lower rates than at BE expert centers
Given these data routine use of NBI prior to EET could significantly impact treatment decisions among all endoscopists with highly accurate rates of dysplasia detection Its been shown that NBI increases the accuracy and positive predictive value of predicting histology than if HD-WLE is used alone This study is limited by the use of still-images which does not accurately reproduce live images seen during endoscopy Nevertheless the current standard of using HD-WLE for identification of visible lesions likely underestimates the presence of dysplastic areas in patients undergoing Endoscopic Eradication Therapy EET for BE-AN We hypothesize that the routine use of narrow band imaging NBI for identification of visible lesions will improve dysplasia detection and have a significant effect on the choice of primary treatment modality among endoscopists performing EET To this end we propose a video-based study to evaluate the impact of NBI on choice of treatment modality during EET
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None