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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03015571
Enrollment
1000
Registered
2017-01-10
Start date
2017-01-10
Completion date
2018-01-09
Last updated
2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heterotopic Gastric Mucosa of the Proximal Esophagus

Keywords

heterotopic gastric mucosa, cervical inlet patch, narrow band imaging, endoscopy

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.

Interventions

DEVICEEsophagus inspection in Narrow Band imaging.

During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection.

DEVICEStandard High definition endoscopy.

Whole procedure will be performed in standard High definition endoscopy.

DEVICEEsophagus inspection in Narrow Band imaging and increased care.

During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection and with increased care of cervical inlet patches detection.

DEVICEStandard High definition endoscopy and increased care.

Whole procedure will be performed in standard High definition endoscopy with increased care of cervical inlet patches detection.

Sponsors

Tomasz Romańczyk
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Detection of heterotopic gastric mucosa in the proximal esophagusDay 1

Secondary

MeasureTime frame
Detection of other upper gastrointestinal lesionsDay 1
Correlation of throat and esophageal reflux symptoms with cervical inlet patchesDay 1
Rate of cervical inlet patches verified with NBI in endoscopies performed in standard white light endoscopyDay 1
Total and esophagus inspection timeDay 1
Correlation of subject's subjective purpose of gastroscopy and cervical inlet patch occurrenceDay 1

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026