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Completed

NCT Number: NCT03015571

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

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

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Key information

Conditions

Heterotopic Gastric Mucosa of the Proximal Esophagus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H-T.Centrum Medyczne Sp. z o.o. Sp. K.

Tychy, Silesian Voivodeship, 43-100, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophagus inspection in Narrow Band imaging.

Device

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

Standard High definition endoscopy.

Device

Whole procedure will be performed in standard High definition endoscopy.

Esophagus inspection in Narrow Band imaging and increased care.

Device

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

Standard High definition endoscopy and increased care.

Device

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

Primary outcomes

  1. Detection of heterotopic gastric mucosa in the proximal esophagus

    Time frame: Day 1

Secondary outcomes

  1. Total and esophagus inspection time

    Time frame: Day 1

  2. Detection of other upper gastrointestinal lesions

    Time frame: Day 1

  3. Correlation of throat and esophageal reflux symptoms with cervical inlet patches

    Time frame: Day 1

  4. Rate of cervical inlet patches verified with NBI in endoscopies performed in standard white light endoscopy

    Time frame: Day 1

  5. Correlation of subject's subjective purpose of gastroscopy and cervical inlet patch occurrence

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Tomasz Romańczyk

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 10, 2017
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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