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临床试验/NCT03824431
NCT03824431已完成不适用

High Definition Endoscopy With NBI. Contribution in Patients With Non-erosive Esophagitis-pHmetric , Esophageal Motility, Histological and Immunohistochemical Associative Findings With Endoscopic Microerosions

University of Sao Paulo General Hospital0 个研究点目标入组 70 人开始时间: 2014年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
主要终点
High definition endoscopy with digital chromoscopy

研究概览

简要总结

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.

详细描述

In this study the investigators focused the attention on patients with symptomatic GERD according to inclusion criteria and used high definition endoscopy with NBI in an attempt to increase the possibility of esophageal microerosion identification. The study was complemented with examinations of esophageal phmetry. During endoscopy, esophageal biopsies were obtained in patients with microerosions and controls (without microerosion). The collected material was evaluated by histopathological and immunohistochemical methods (interleukins-IL6, IL8 and IL1β) in an attempt to identify inflammatory alterations. The results of this investigation could contribute to the evaluation of microerosions as an early and significant abnormality with possible participation in the pathophysiology of GERD.

General objectives To validate the presence and clinical significance of endoscopic microerosions in patients submitted to esophageal mucosal biopsies, with typical symptoms of gastroesophageal reflux, using high definition endoscopy with (NBI), prolonged pHmetry, histopathological and immuno- histochemistry.

Specific objectives

  1. Validate the presence of microerosions in the distal esophagus, as found in high-resolution endoscopy with NBI, in patients with typical symptoms of Gastroesophageal Reflux Disease.
  2. Verify the association of microerosions in the distal esophagus in high-resolution endoscopy exams with NBI, with the manometric findings of esophageal perfusion manometry.
  3. To observe the changes in the prolonged pHmetry in patients with microerosions in the distal esophagus through high definition endoscopy with NBI.
  4. To evaluate the significance of the histological and immunohistochemical changes of tissue specimens obtained in esophageal biopsies of patients with microerosions in the distal esophagus, in high definition endoscopy with NBI.

This is a prospective, descriptive and cross-sectional study that included 90 patients, with GERD complaints. Seventy patients were selected as the object of study according to previously established inclusion and exclusion criteria. The selected patients were informed about their participation and signed an informed consent term. The histopathology and immunohistochemistry studies were carried out in the Department of Pathology of the same institution.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • BMI (Body Mass Index) > 30 kg / m2
  • Pregnant women
  • Recent use of anticoagulants
  • Comorbidities that may interfere with esophageal motility
  • Recent use of PPI (Proton Pump Inhibitor) <7 days.

结局指标

主要结局

High definition endoscopy with digital chromoscopy

时间窗: 2 days

Presence or absence of microerosions in distal esophagus.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomas Navarro Rodriguez

Clinical Professor

University of Sao Paulo General Hospital

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