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

Not Applicable

Completed

• Conditions: Heterotopic Gastric Mucosa of the Proximal Esophagus
• Interventions: Device: Standard High definition endoscopy.; Device: Esophagus inspection in Narrow Band imaging and increased care.; Device: Esophagus inspection in Narrow Band imaging.; Device: Standard High definition endoscopy and increased care.

• Registration Number: NCT03015571
• Lead Sponsor: Tomasz Romańczyk

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-12-29
• Study First Submitted QC: 2017-01-06
• Study Start: 2017-01-10
• Study First Posted: 2017-01-10
• Primary Completion: 2018-01-09
• Study Completion: 2018-01-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WL	Standard High definition endoscopy.	Use of High Definition White Light (WL) with regular care of cervical inlet patches detection.
NBI increased care	Esophagus inspection in Narrow Band imaging and increased care.	Use of Narrow Band Imaging with increased care of cervical inlet patches detection.
NBI	Esophagus inspection in Narrow Band imaging.	Use of Narrow Band Imaging with regular care of cervical inlet patches detection.
WL increased care	Standard High definition endoscopy and increased care.	Use of High Definition White Light (WL) with increased care of cervical inlet patches detection.

Primary Outcome Measures

Name	Time	Method
Detection of heterotopic gastric mucosa in the proximal esophagus	Day 1

Secondary Outcome Measures

Name	Time	Method
Total and esophagus inspection time	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
Detection of other upper gastrointestinal lesions	Day 1
Correlation of throat and esophageal reflux symptoms with cervical inlet patches	Day 1

Trial Locations

Locations (1)

H-T.Centrum Medyczne Sp. z o.o. Sp. K.; 🇵🇱 Tychy, Silesia, Poland