High Definition Endoscopy With NBI. Contribution in Patients With Non-erosive Esophagitis
Condition: GERD
MeSH terms: Esophagitis
Study type: Observational [Patient Registry]

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.
    

Detailed description: 
      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.

      The study patients were evaluated after selection according to the inclusion and exclusion
      criteria on two occasions. On the first day, the examinations of esophageal manometry and
      phmetria were performed. The next day the pHmetry probe was removed and then the high
      definition endoscopy with NBI and the biopsies in the distal esophagus were performed. This
      approach facilitated patient adherence, especially in relation to logistics in performing the
      tests, and could represent more accurately the association of the tests performed. It was
      previously established that incomplete data from the exams would lead to the exclusion of the
      patient from the study.
    

Intervention name(s): Endoscopic esophageal biopsies
Intervention type(s): Diagnostic Test
Other intervention name(s): esophageal manometry; esophageal phmetry; esophageal biopsies
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Outpatients from the Gastroenterology Clinic (University of Sao Paulo)
      
Keywords: Gastroesophageal reflux disease; Narrow Band Imaging; High definition endoscopy; Microerosions; Esophageal biopsy; Immunohistochemistry.