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

NCT ID: NCT03015571

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-10

Study Completion Date

2018-01-09

Brief Summary

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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

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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.

Conditions

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Heterotopic Gastric Mucosa of the Proximal Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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NBI

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

Group Type EXPERIMENTAL

Esophagus inspection in Narrow Band imaging.

Intervention Type DEVICE

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

WL

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

Group Type PLACEBO_COMPARATOR

Standard High definition endoscopy.

Intervention Type DEVICE

Whole procedure will be performed in standard High definition endoscopy.

NBI increased care

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

Group Type EXPERIMENTAL

Esophagus inspection in Narrow Band imaging and increased care.

Intervention Type DEVICE

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

WL increased care

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

Group Type PLACEBO_COMPARATOR

Standard High definition endoscopy and increased care.

Intervention Type DEVICE

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

Interventions

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Esophagus inspection in Narrow Band imaging.

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

Intervention Type DEVICE

Standard High definition endoscopy.

Whole procedure will be performed in standard High definition endoscopy.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tomasz Romańczyk

OTHER

Sponsor Role lead

Responsible Party

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Tomasz Romańczyk

Principal Investigator Tomasz Romańczyk MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Tychy, Silesian Voivodeship, Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 15056100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10929900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23372354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20437050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24890619 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24415878 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25059461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26562398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17450028 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35809096 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33640715 (View on PubMed)

Related Links

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http://www.giejournal.org/article/S0016-5107(10)01071-0/fulltext

Incidence of Heterotopic Gastric Mucosa in the Upper Esophagus in First Time Narrow Banding Image Endoscopy.

Other Identifiers

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HT-001

Identifier Type: -

Identifier Source: org_study_id

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