| Registry | NCT03015571 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, diagnostic |
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| Enrollment | 1000 (Estimated) |
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| Sponsor | Tomasz Romańczyk (Other) |
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| Conditions | Heterotopic Gastric Mucosa of the Proximal Esophagus |
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| Interventions | 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. (Device) |
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| Dates | start 2017-01-10, primary completion 2018-01-09, completion 2018-01-09, first posted 2017-01-10, last updated 2018-08-31 |
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| Locations | 1 site in Poland |
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Related Papers Related Patents Related Grants Related Experts
All trials for Heterotopic Gastric Mucosa of the Proximal Esophagus All trials of Esophagus inspection in Narrow Band imaging. All trials of Standard High definition endoscopy.
-Summary
The aim of the study is to determine whether Narrow Band Imaging(NBI) should be routinely used during esophagus inspection at diagnostic gastroscopy.
Expand all sections · Collapse all
+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| NBI | Experimental | Device: Esophagus inspection in Narrow Band imaging. | Use of Narrow Band Imaging with regular care of cervical inlet patches detection. |
| WL | Placebo comparator | Device: Standard High definition endoscopy. | Use of High Definition White Light (WL) with regular care of cervical inlet patches detection. |
| NBI increased care | Experimental | Device: Esophagus inspection in Narrow Band imaging and increased care. | Use of Narrow Band Imaging with increased care of cervical inlet patches detection. |
| WL increased care | Placebo comparator | Device: Standard High definition endoscopy and increased care. | Use of High Definition White Light (WL) with increased care of cervical inlet patches detection. |
- 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.
+Outcome measures
Primary outcomes
- Detection of heterotopic gastric mucosa in the proximal esophagus [Day 1]
Secondary outcomes
- 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]
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| H-T.Centrum Medyczne Sp. z o.o. Sp. K. | Tychy, Silesian Voivodeship | Poland | |
+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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 17450028
- Results publication: 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 35809096
- Results publication: 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 33640715