NCT03015571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 10, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

12 months

First QC Date

December 29, 2016

Last Update Submit

August 29, 2018

Conditions

Heterotopic Gastric Mucosa of the Proximal Esophagus

Keywords

heterotopic gastric mucosacervical inlet patchnarrow band imagingendoscopy

Outcome Measures

Primary Outcomes (1)

  • Detection of heterotopic gastric mucosa in the proximal esophagus

    Day 1

Secondary Outcomes (5)

  • Total and esophagus inspection time

    Day 1

  • Detection of other upper gastrointestinal lesions

    Day 1

  • Correlation of throat and esophageal reflux symptoms with cervical inlet patches

    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 Arms (4)

NBI

EXPERIMENTAL

Use of Narrow Band Imaging with regular care of cervical inlet patches detection.

Device: Esophagus inspection in Narrow Band imaging.

WL

PLACEBO COMPARATOR

Use of High Definition White Light (WL) with regular care of cervical inlet patches detection.

Device: Standard High definition endoscopy.

NBI increased care

EXPERIMENTAL

Use of Narrow Band Imaging with increased care of cervical inlet patches detection.

Device: Esophagus inspection in Narrow Band imaging and increased care.

WL increased care

PLACEBO COMPARATOR

Use of High Definition White Light (WL) with increased care of cervical inlet patches detection.

Device: Standard High definition endoscopy and increased care.

Interventions

Esophagus inspection in Narrow Band imaging.DEVICE

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

NBI
Standard High definition endoscopy.DEVICE

Whole procedure will be performed in standard High definition endoscopy.

WL
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.

NBI increased care
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.

WL increased care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \<18
  • Prisoners
  • Pregnancy
  • Gastroscopy with treatment procedure
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tychy, Silesian Voivodeship, 43-100, Poland

Location

Related Publications (11)

  • von Rahden BH, Stein HJ, Becker K, Liebermann-Meffert D, Siewert JR. Heterotopic gastric mucosa of the esophagus: literature-review and proposal of a clinicopathologic classification. Am J Gastroenterol. 2004 Mar;99(3):543-51. doi: 10.1111/j.1572-0241.2004.04082.x.

    PMID: 15056100BACKGROUND

  • Maconi G, Pace F, Vago L, Carsana L, Bargiggia S, Bianchi Porro G. Prevalence and clinical features of heterotopic gastric mucosa in the upper oesophagus (inlet patch). Eur J Gastroenterol Hepatol. 2000 Jul;12(7):745-9. doi: 10.1097/00042737-200012070-00005.

    PMID: 10929900BACKGROUND

  • Chong VH. Clinical significance of heterotopic gastric mucosal patch of the proximal esophagus. World J Gastroenterol. 2013 Jan 21;19(3):331-8. doi: 10.3748/wjg.v19.i3.331.

    PMID: 23372354BACKGROUND

  • Chong VH, Jalihal A. Heterotopic gastric mucosal patch of the esophagus is associated with higher prevalence of laryngopharyngeal reflux symptoms. Eur Arch Otorhinolaryngol. 2010 Nov;267(11):1793-9. doi: 10.1007/s00405-010-1259-2. Epub 2010 May 1.

    PMID: 20437050BACKGROUND

  • Al-Mammari S, Selvarajah U, East JE, Bailey AA, Braden B. Narrow band imaging facilitates detection of inlet patches in the cervical oesophagus. Dig Liver Dis. 2014 Aug;46(8):716-9. doi: 10.1016/j.dld.2014.05.001. Epub 2014 Jun 2.

    PMID: 24890619BACKGROUND

  • Cheng CL, Lin CH, Liu NJ, Tang JH, Kuo YL, Tsui YN. Endoscopic diagnosis of cervical esophageal heterotopic gastric mucosa with conventional and narrow-band images. World J Gastroenterol. 2014 Jan 7;20(1):242-9. doi: 10.3748/wjg.v20.i1.242.

    PMID: 24415878BACKGROUND

  • Chung CS, Lin CK, Liang CC, Hsu WF, Lee TH. Intentional examination of esophagus by narrow-band imaging endoscopy increases detection rate of cervical inlet patch. Dis Esophagus. 2015 Oct;28(7):666-72. doi: 10.1111/dote.12252. Epub 2014 Jul 24.

    PMID: 25059461BACKGROUND

  • Vesper I, Schmiegel W, Brechmann T. Equal detection rate of cervical heterotopic gastric mucosa in standard white light, high definition and narrow band imaging endoscopy. Z Gastroenterol. 2015 Nov;53(11):1247-54. doi: 10.1055/s-0041-104226. Epub 2015 Nov 12.

    PMID: 26562398BACKGROUND

  • Azar C, Jamali F, Tamim H, Abdul-Baki H, Soweid A. Prevalence of endoscopically identified heterotopic gastric mucosa in the proximal esophagus: endoscopist dependent? J Clin Gastroenterol. 2007 May-Jun;41(5):468-71. doi: 10.1097/01.mcg.0000225519.59030.8d.

    PMID: 17450028BACKGROUND

  • Romanczyk M, Budzyn K, Romanczyk T, Lesinska M, Koziej M, Hartleb M, Waluga M. Heterotopic Gastric Mucosa in the Proximal Esophagus: Prospective Study and Systematic Review on Relationships with Endoscopic Findings and Clinical Data. Dysphagia. 2023 Apr;38(2):629-640. doi: 10.1007/s00455-022-10492-8. Epub 2022 Jul 9.

    PMID: 35809096DERIVED

  • Romanczyk M, Romanczyk T, Lesinska M, Romanczyk A, Hartleb M, Waluga M. Influence of narrow-band imaging (NBI) and enhanced operator's attention during esophagus inspection on cervical inlet patches detection. Adv Med Sci. 2021 Mar;66(1):170-175. doi: 10.1016/j.advms.2021.02.002. Epub 2021 Feb 25.

    PMID: 33640715DERIVED

Related Links

MeSH Terms

Interventions

Narrow Band Imaging

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator Tomasz Romańczyk MD, PhD

Study Record Dates

First Submitted

December 29, 2016

First Posted

January 10, 2017

Study Start

January 10, 2017

Primary Completion

January 9, 2018

Study Completion

January 9, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)