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Clinical Trials/NCT05876702
NCT05876702UnknownNot Applicable

Endoscopic I-scan Versus Histopathological Evaluation Of Esophageal Lesions

Sohag University1 site in 1 country30 target enrollmentStarted: May 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
detection of esophageal lesions

Study Overview

Brief Summary

Considering esophageal diseases, according to a cross-sectional study of endoscopic findings in patients who underwent upper endoscopy at the Fayoum University Hospital, the most common esophageal conditions seen with the endoscope were esophageal varices (25.6% of cases), GERD (23.8% of cases), esophagitis (7.4% of cases), and esophageal monilasis.

GERD is characterized by dystressing symptoms and consequences brought on by the reflux of stomach contents. (Vakil et al., 2006)It appears that the 2 main GERD phenotypes have different pathophysiological and clinical characteristics. In addition, the response to antireflux medication varied significantly between NERD and erosive esophagitis. Patients with NERD made up the majority of the group with refractory heartburn because they had a noticeably lower response rate to proton pump inhibitor (PPI) therapy.

Barrett's oesophagus (BO) and oesophageal adenocarcinoma, may develop as a result of GERD. Barrett's oesophagus is characterised by intestinal metaplasia, which is characterised by acid mucin-containing goblet cells, and the replacement of any length of the squamous epithelium in the distal oesophagus by columnar epithelium.

Dysphagia is frequently brought on by esophageal cancer, which is a serious public health issue. In 2003, there were an estimated 13,900 new instances of esophageal cancer in the US, and 13,000 people passed away from the disease. Only 13% of people survive five years.

High-resolution white-light endoscopy during gastroscopy can identify abnormalities in the mucosa. The endoscopist must decide if the aetiology of erosions, ulcers, strictures, or metaplasia is non-neoplastic or cancerous if they are discovered. Discoloration, a grainy appearance (orange peel effect), and small lumps and depressions in Barrett's layer are indications of dysplasia.

The high-definition I-Scan was created by Pentax (HOYA, Japan) and is based on processing the picture captured by the endoscope's CCD (charge coupled device) to enhance the contrast of the vascular structures and the patterns of the digestive tract's mucosa.(Andrés Reyes-Dorantes, 2011)For the situations outlined below, some authors advise using the I-Scan modes:I-Scan 1 (SE) thought to be used to find lesions. Without affecting the clarity of the endoscopic image, it sharpens the image of minute surface defects,the I-Scan 2 (TE plus SE) imaging system should be utilized to characterize lesions. It increases subtle alterations in the mucosa and vascular architecture while combining surface and tone augmentation and for defining lesions, I-Scan 3 (TE plus CE) should be utilized. The margins of the endoscopic image are darkened and blue colour is digitally added.

In patients with gastrointestinal diseases, endoscopic biopsy and histological evaluation enable early diagnosis of precancerous and cancerous tumours and prompt disease therapy.(Afzal et al., 2006)The results of specimens from a study conducted over five years (2004-2008) in the pathology departments of Cairo University's faculty of medicine and the Theodor Bilharz Research Institute in Egypt were as follows: 54.76% of the 210 esophageal specimens had GERD, 17.61% had Barrett's oesophagus, 3.81% had benign lesions, 18.6% had malignant lesions (squamous cell carcinoma, adenocarcinoma, and undifferentiated carcinoma, each accounting for 10.48% of the total), and 5.24% had other conditions.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •: All patients with any gastro-esophageal symptoms who underwent upper endoscopy at the endoscopy unit of Tropical medicine and Gastroenterology department will be included.

Exclusion Criteria

  • •Any cirrhotic patient.

Outcomes

Primary Outcomes

detection of esophageal lesions

Time Frame: 12 months

comparison between number of lesions that could be detected by upper endoscopy and lesions detected by histopathological examination of taken biopsies

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Mokhtar Sadik

Resident-Tropical medecine department-sohag hospital university

Sohag University

Study Sites (1)

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