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

August 29, 2018 updated by: Tomasz Romańczyk
The aim of the study is to determine whether Narrow Band Imaging(NBI) should be routinely used during esophagus inspection at diagnostic gastroscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Silesia
      • Tychy, Silesia, Poland, 43-100
        • H-T.Centrum Medyczne Sp. z o.o. Sp. K.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detection of heterotopic gastric mucosa in the proximal esophagus
Time Frame: Day 1
Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomasz Romańczyk

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2017

Primary Completion (Actual)

January 9, 2018

Study Completion (Actual)

January 9, 2018

Study Registration Dates

First Submitted

December 29, 2016

First Submitted That Met QC Criteria

January 6, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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