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AzTrials

Heterotopic Gastric Mucosa of the Proximal EsophagusNCT03015571

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

A study testing Esophagus inspection in Narrow Band imaging., Standard High definition endoscopy. and Esophagus inspection in Narrow Band imaging and increased care. in people with Heterotopic Gastric Mucosa of the Proximal Esophagus, run by Tomasz Romańczyk at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Esophagus inspection in Narrow Band imaging., Standard High definition endoscopy. and Esophagus inspection in Narrow Band imaging and increased care.
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
1 sitePoland
Study dates
10 Jan 2017to 9 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Poland1 site

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

    Tychy, Silesian Voivodeship, 43-100

Other trials in Poland

About this study

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

Read the 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.

Being tested
Esophagus inspection in Narrow Band imaging., Standard High definition endoscopy., Esophagus inspection in Narrow Band imaging and increased care., Standard High definition endoscopy and increased care.
Keywords
heterotopic gastric mucosa, cervical inlet patch, narrow band imaging, endoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03015571
Study groupRoleWhat they receive
NBIExperimentalUse of Narrow Band Imaging with regular care of cervical inlet patches detection.
Receives: Device: Esophagus inspection in Narrow Band imaging.
WLPlacebo comparatorUse of High Definition White Light (WL) with regular care of cervical inlet patches detection.
Receives: Device: Standard High definition endoscopy.
NBI increased careExperimentalUse of Narrow Band Imaging with increased care of cervical inlet patches detection.
Receives: Device: Esophagus inspection in Narrow Band imaging and increased care.
WL increased carePlacebo comparatorUse of High Definition White Light (WL) with increased care of cervical inlet patches detection.
Receives: Device: Standard High definition endoscopy and increased care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection of heterotopic gastric mucosa in the proximal esophagus

    Measured: Day 1

Secondary outcomes (5)

  1. Total and esophagus inspection time

    Measured: Day 1

  2. Detection of other upper gastrointestinal lesions

    Measured: Day 1

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

    Measured: Day 1

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

    Measured: Day 1

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

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2017 (estimated)
  2. Study start10 Jan 2017
  3. Primary completion9 Jan 2018
  4. Study completion9 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03015571
Sponsor's protocol ID
HT-001
Status last verified
Aug 2018
First submitted
29 Dec 2016
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 15056100

  • 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.

    PubMed 10929900

  • 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.

    PubMed 23372354

  • 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.

    PubMed 20437050

  • 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.

    PubMed 24890619

  • 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.

    PubMed 24415878

  • 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.

    PubMed 25059461

  • 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.

    PubMed 26562398

  • 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.

    PubMed 17450028

  • 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.

    PubMed 35809096

  • 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.

    PubMed 33640715

Questions about this trial

What is this clinical trial studying?

A study testing Esophagus inspection in Narrow Band imaging., Standard High definition endoscopy. and Esophagus inspection in Narrow Band imaging and increased care. in people with Heterotopic Gastric Mucosa of the Proximal Esophagus, run by Tomasz Romańczyk at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of heterotopic gastric mucosa in the proximal esophagus (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03015571, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.

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