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

Tomasz Romańczyk

Status: Completed

Conditions: Heterotopic Gastric Mucosa of the Proximal Esophagus

Treatments: Device: Standard High definition endoscopy.; Device: Esophagus inspection in Narrow Band imaging and increased care.; Device: Esophagus inspection in Narrow Band imaging.; Device: Standard High definition endoscopy and increased care.

Study type: Interventional

Funder types: Other

Identifiers

NCT03015571

HT-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 4 patient groups, including a placebo group

NBI

Experimental group

Description:

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

Treatment:

Device: Esophagus inspection in Narrow Band imaging.

WL

Placebo Comparator group

Description:

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

Treatment:

Device: Standard High definition endoscopy.

NBI increased care

Experimental group

Description:

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

Treatment:

Device: Esophagus inspection in Narrow Band imaging and increased care.

WL increased care

Placebo Comparator group

Description:

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

Treatment:

Device: Standard High definition endoscopy and increased care.