NCT03824431

Brief Summary

Most patients with symptomatic gastroesophageal reflux disease (GERD) have a normal upper gastrointestinal endoscopy. Attempts have been made to define new endoscopic techniques for identification of abnormalities non detected in standard endoscopic exam. The high definition endoscopy with NBI could achieve a more detailed mucosal evaluation, allowing distal esophageal microerosions identification. The objective was validate the presence and the meaning of distal esophageal mucosal microerosions using high definition endoscopy and NBI through esophageal biopsy in gastroesophageal reflux disease symptomatic patients and the association with GERD physiopathology. Seventy patients were selected from the gastroenterology outpatient clinic (University of Sao Paulo Hospital) Endoscopic evaluation was sequentially performed after the pHmetry and esophageal manometry. Esophageal mucosal biopsies were obtained following established protocol for histological and immunohistochemical study.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

January 29, 2019

Last Update Submit

February 13, 2019

Conditions

GERD

Keywords

Gastroesophageal reflux diseaseNarrow Band ImagingHigh definition endoscopyMicroerosionsEsophageal biopsyImmunohistochemistry.

Outcome Measures

Primary Outcomes (1)

  • High definition endoscopy with digital chromoscopy

    Presence or absence of microerosions in distal esophagus.

    2 days

Study Arms (2)

patients with endoscopic microerosions

==Patients with typical symptoms of Gastroesophageal Reflux Disease(GERD): 1- High resolution definition with NBI endoscopic findings of mucosal microerosions in distal esophagus . .

Diagnostic Test: Endoscopic esophageal biopsies

patients without microerosions

2- High resolution definition with NBI endoscopic without findings of mucosal microerosions in distal esophagus .

Diagnostic Test: Endoscopic esophageal biopsies

Interventions

Endoscopic esophageal biopsiesDIAGNOSTIC_TEST
Also known as: esophageal manometry, esophageal phmetry, esophageal biopsies
patients with endoscopic microerosionspatients without microerosions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatients from the Gastroenterology Clinic (University of Sao Paulo)

You may qualify if:

  • Outpatients aged 18 to 70 years
  • Patients with symptoms typical of GERD, on at least two different days over a week, for a period of at least three consecutive months, and with conventional upper gastrointestinal endoscopy (UGE) without oesophageal changes, performed in the last 12 months.

You may not qualify if:

  • Hiatal hérnia
  • Ulcers of the upper digestive tract
  • Drugs that interfere with the physiology of the esophagus
  • Esophago-gastric surgeries
  • Achalasia of the esophagus
  • Esophagitis (erosive, eosinophilic, medicinal, infectious, non-erosive to conventional endoscopy)
  • Esophageal stricture
  • Esophageal varices
  • Clinical situations that prevent more detailed evaluation of the Escamo-colunar junction during endoscopy (psychomotor-agitation, cough)
  • Barrett's Esophagus
  • Esophageal diverticulum
  • Atrophic gastritis
  • Recent use of anti-inflammatories \<30 days
  • Systemic inflammatory / immune systemic diseases of the gastrointestinal tract
  • Recent Infectious Diseases \<30 days
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 31, 2019

Study Start

January 23, 2014

Primary Completion

November 4, 2016

Study Completion

November 20, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02