Influence of Routine Use of Narrow Band Imaging on Heterotopic Gastric Mucosa of the Proximal Esophagus Detection

Study Overview
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Brief Summary
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The aim of the study is to determine whether Narrow Band Imaging(NBI) should be routinely used during esophagus inspection at diagnostic gastroscopy.

Detailed Description
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Heterotopic gastric mucosa, also called inlet patch, is area of ectopic gastric mucosa with common location at proximal part of esophagus. Because of the location, lesions are likely to be missed during routine gastroscopy. The clinical significance of inlet patches remains unknown, however they may be symptomatic and may cause morphologic changes such as strictures, ulcers, webs, stenoses or even adenocarcinomas. Moreover inlet patches may be correlated with reflux symptoms up to 73,1%. Several studies were conducted to determine whether NBI improves detection of cervical inlet patches, some of them were also prospective studies, however no randomized study was conducted.

Official Title
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Influence of Routine Use of Narrow Band Imaging on Heterotopic Gastric Mucosa of the Proximal Esophagus Detection

Conditions
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Heterotopic Gastric Mucosa of the Proximal Esophagus

Intervention / Treatment
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* Device: Esophagus inspection in Narrow Band imaging.
* Device: Standard High definition endoscopy.
* Device: Esophagus inspection in Narrow Band imaging and increased care.
* Device: Standard High definition endoscopy and increased care.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referral for diagnostic gastroscopy Ability to undergo diagnostic gastroscopy Provided written informed consent Exclusion Criteria: Age <18 Prisoners Pregnancy Gastroscopy with treatment procedure Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBI<br>Use of Narrow Band Imaging with regular care of cervical inlet patches detection. | Device: Esophagus inspection in Narrow Band imaging.<br>* During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection.<br>|
| Placebo Comparator: WL<br>Use of High Definition White Light (WL) with regular care of cervical inlet patches detection. | Device: Standard High definition endoscopy.<br>* Whole procedure will be performed in standard High definition endoscopy.<br>|
| Experimental: NBI increased care<br>Use of Narrow Band Imaging with increased care of cervical inlet patches detection. | Device: Esophagus inspection in Narrow Band imaging and increased care.<br>* During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection and with increased care of cervical inlet patches detection.<br>|
| Placebo Comparator: WL increased care<br>Use of High Definition White Light (WL) with increased care of cervical inlet patches detection. | Device: Standard High definition endoscopy and increased care.<br>* Whole procedure will be performed in standard High definition endoscopy with increased care of cervical inlet patches detection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of heterotopic gastric mucosa in the proximal esophagus |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total and esophagus inspection time |  | Day 1 | 
| Detection of other upper gastrointestinal lesions |  | Day 1 | 
| Correlation of throat and esophageal reflux symptoms with cervical inlet patches |  | Day 1 | 
| Rate of cervical inlet patches verified with NBI in endoscopies performed in standard white light endoscopy |  | Day 1 | 
| Correlation of subject's subjective purpose of gastroscopy and cervical inlet patch occurrence |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heterotopic gastric mucosa, cervical inlet patch, narrow band imaging, endoscopy