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Clinical Trials/NCT03015571
NCT03015571
Completed
Not Applicable

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

Tomasz Romańczyk1 site in 1 country1,000 target enrollmentJanuary 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heterotopic Gastric Mucosa of the Proximal Esophagus
Sponsor
Tomasz Romańczyk
Enrollment
1000
Locations
1
Primary Endpoint
Detection of heterotopic gastric mucosa in the proximal esophagus
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2017
End Date
January 9, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tomasz Romańczyk
Responsible Party
Sponsor Investigator
Principal Investigator

Tomasz Romańczyk

Principal Investigator Tomasz Romańczyk MD, PhD

H-T. Centrum Medyczne Sp. z o.o. sp. k

Eligibility Criteria

Inclusion Criteria

  • Referral for diagnostic gastroscopy
  • Ability to undergo diagnostic gastroscopy
  • Provided written informed consent

Exclusion Criteria

  • Prisoners
  • Pregnancy
  • Gastroscopy with treatment procedure
  • Inability to provide informed consent

Outcomes

Primary Outcomes

Detection of heterotopic gastric mucosa in the proximal esophagus

Time Frame: Day 1

Secondary Outcomes

  • Detection of other upper gastrointestinal lesions(Day 1)
  • Correlation of throat and esophageal reflux symptoms with cervical inlet patches(Day 1)
  • 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)

Study Sites (1)

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