Clinical trial NCT05876702: Endoscopic I-scan Versus Histopathological Evaluation Of Esophageal Lesions
Official title: Endoscopic I-scan Versus Histopathological Evaluation Of Esophageal Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Lesions
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: detection of esophageal lesions
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.