Endoscopic I-scan Versus Histopathological Evaluation Of Esophageal Lesions

NCT ID: NCT05876702

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Lesions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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endoscopy

use of upper endoscopy with i-scan specially , in diagnosis of esophageal lesions and comparison of results with histopathology.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Michael Mokhtar Sadik

Resident-Tropical medecine department-sohag hospital university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Michael M Sadik, resident

Role: CONTACT

01093497787

El-zahraa M Megheizel, assistant professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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Fass R, Sifrim D. Management of heartburn not responding to proton pump inhibitors. Gut. 2009 Feb;58(2):295-309. doi: 10.1136/gut.2007.145581.

Reference Type BACKGROUND
PMID: 19136523 (View on PubMed)

Galloro G. High technology imaging in digestive endoscopy. World J Gastrointest Endosc. 2012 Feb 16;4(2):22-7. doi: 10.4253/wjge.v4.i2.22.

Reference Type BACKGROUND
PMID: 22347528 (View on PubMed)

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34. doi: 10.3322/caac.21551. Epub 2019 Jan 8.

Reference Type BACKGROUND
PMID: 30620402 (View on PubMed)

Spechler SJ. Barrett esophagus and risk of esophageal cancer: a clinical review. JAMA. 2013 Aug 14;310(6):627-36. doi: 10.1001/jama.2013.226450.

Reference Type BACKGROUND
PMID: 23942681 (View on PubMed)

Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.

Reference Type BACKGROUND
PMID: 16928254 (View on PubMed)

Other Identifiers

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Soh-Med-23-05-05MS

Identifier Type: -

Identifier Source: org_study_id

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