Clinical trial NCT03015571: Influence of Routine Use of Narrow Band Imaging on Heterotopic Gastric Mucosa of the Proximal Esophagus Detection
Official title: Influence of Routine Use of Narrow Band Imaging on Heterotopic Gastric Mucosa of the Proximal Esophagus Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heterotopic Gastric Mucosa of the Proximal Esophagus
Keywords: heterotopic gastric mucosa
cervical inlet patch
narrow band imaging
endoscopy
Lead sponsor: H-T. Centrum Medyczne Sp. z o.o. sp. k
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Detection of heterotopic gastric mucosa in the proximal esophagus
timeFrame: Day 1
Secondary outcomes:
measure: Total and esophagus inspection time
timeFrame: Day 1
measure: Detection of other upper gastrointestinal lesions
timeFrame: Day 1
measure: Correlation of throat and esophageal reflux symptoms with cervical inlet patches
timeFrame: Day 1
measure: Rate of cervical inlet patches verified with NBI in endoscopies performed in standard white light endoscopy
timeFrame: Day 1
measure: Correlation of subject's subjective purpose of gastroscopy and cervical inlet patch occurrence
timeFrame: Day 1
Other outcomes:
Locations:
city: Tychy
country: Poland
facility: H-T.Centrum Medyczne Sp. z o.o. Sp. K.
state: Silesia
Study officials:
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.