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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBI | Experimental | Use of Narrow Band Imaging with regular care of cervical inlet patches detection. |
|
| WL | Placebo Comparator | Use of High Definition White Light (WL) with regular care of cervical inlet patches detection. |
|
| NBI increased care | Experimental | Use of Narrow Band Imaging with increased care of cervical inlet patches detection. |
|
| WL increased care | Placebo Comparator | Use of High Definition White Light (WL) with increased care of cervical inlet patches detection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagus inspection in Narrow Band imaging. | Device | During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of heterotopic gastric mucosa in the proximal esophagus | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H-T.Centrum Medyczne Sp. z o.o. Sp. K. | Tychy | Silesian Voivodeship | 43-100 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15056100 | Background | 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. | |
| 10929900 | Background | 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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| 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. |
|
| 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 |
| 23372354 | Background | 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. |
| 20437050 | Background | 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. |
| 24890619 | Background | 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. |
| 24415878 | Background | 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. |
| 25059461 | Background | 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. |
| 26562398 | Background | 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. |
| 17450028 | Background | 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. |
| 35809096 | Derived | 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. |
| 33640715 | Derived | 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. |
| ID | Term |
|---|---|
| D062048 | Narrow Band Imaging |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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