Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015571
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Tomasz Romańczyk, H-T. Centrum Medyczne Sp. z o.o. sp. k

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.

Condition or disease Intervention/treatment Phase
Heterotopic Gastric Mucosa of the Proximal Esophagus Device: Esophagus inspection in Narrow Band imaging. Device: Standard High definition endoscopy. Device: Esophagus inspection in Narrow Band imaging and increased care. Device: Standard High definition endoscopy and increased care. Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Influence of Routine Use of Narrow Band Imaging on Heterotopic Gastric Mucosa of the Proximal Esophagus Detection
Actual Study Start Date : January 10, 2017
Actual Primary Completion Date : January 9, 2018
Actual Study Completion Date : January 9, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Detection of heterotopic gastric mucosa in the proximal esophagus [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015571


Locations
Layout table for location information
Poland
H-T.Centrum Medyczne Sp. z o.o. Sp. K.
Tychy, Silesia, Poland, 43-100
Sponsors and Collaborators
Tomasz Romańczyk
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Tomasz Romańczyk, Principal Investigator Tomasz Romańczyk MD, PhD, H-T. Centrum Medyczne Sp. z o.o. sp. k
ClinicalTrials.gov Identifier: NCT03015571    
Other Study ID Numbers: HT-001
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tomasz Romańczyk, H-T. Centrum Medyczne Sp. z o.o. sp. k:
heterotopic gastric mucosa
cervical inlet patch
narrow band imaging
endoscopy