Clinical trial NCT04622098: Prevalence of Sub-epithelial Lesions Among Patients Undergoing EGDs in Egypt
Official title: Prevalence of Sub-epithelial Lesions Among Patients Undergoing EGDs in Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Neoplasms
Gastric Neoplasm
Duodenal Neoplasms
Keywords: sub-epithelial lesions
esophagogastrodudenoscopy
EUS FNA/FNB
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
Collaborators: name: Mansoura University Hospital
name: Menoufia University
name: Al-Azhar University
name: Assiut University
First posted: 2020-11-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presented to endoscopy units participating in the study and in need for upper endoscopy will be given informed written consent to participate in the study. Possible complications will be described clearly to the patients before the endoscopic procedure. Complete medical history will be recorded specially symptoms suggesting GIT bleeding as hematemesis, melena, or manifestations of anemia. Symptoms suggesting malignancy as weight loss, anorexia, history of previous malignancies will be recorded. Past history of endoscopic procedures, of having previous GIT troubles and of any chronic medical illness or medications will be recorded. Vital signs will be taken for the patients before beginning the endoscopic procedure and after being evaluated by an anesthetist.

Brief summary: Subepithelial lesions (SEL) are incidentally observed in the stomach of about 0.3% of middle-aged men and women; half of these are neoplastic. The incidence of subepithelial tumors (SET) of gastrointestinal (GI) origin has risen twofold to fivefold within the past 30 years.The etiology of most SMTs cannot easily be determined by endoscopy. So, we aim to estimate the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.

Detailed description: Worldwide, the gastrointestinal (GI) tract is the organ system with the highest cancer incidence (20.5% of all new cases) and annual mortality (22% = 1.81 Mio). Early endoscopic detection and resection has led to improved survival rates for colorectal and gastric cancer, especially for gastric cancer in Japan, where more than 70% are now detected as early gastric cancer. Subepithelial lesions (SELs) of the GI tract are tumors that originate from the muscularis mucosa, submucosa, or muscularis propria. The term subepithelial lesion is preferred to the term submucosal tumor, which should be reserved for those that originate from the submucosal layer. SELs are most commonly found in the stomach, as often as 1 in every 300 endoscopies. The majority of these tumors are benign, with fewer than 15% found to be malignant at presentation.

Subepithelial lesions (SEL) are incidentally observed in the stomach of about 0.3% of middle-aged men and women; half of these are neoplastic. The incidence of subepithelial tumors (SET) of gastrointestinal (GI) origin has risen twofold to fivefold within the past 30 years.

According to the Korea EUS Study Group (unpublished data), the prevalence of gastric SETs, detected routine esophagogastroduodenoscopy, in Korea is 3.1%.

The etiology of most SMTs cannot easily be determined by endoscopy. Subepithelial lesions are those located beneath the epithelium and originate from any layer of the gastrointestinal wall. EUS is the best imaging modality to assess gastrointestinal subepithelial lesions and can be used for EUS guided tissue sampling, in addition to diagnostic imaging of the nodule. It helps to distinguish extrinsic lesions from intramural ones based on the originating layer, echogenicity and tissue acquisition to reach an accurate diagnosis. In clinical practice, cytological and immunocytochemical results determine the final diagnosis. EUS is superior to other imaging modalities (CT, magnetic resonance imaging) in characterizing small (\<2 cm) lesions.

NCCN guideline on GISTs recommends resection of all symptomatic lesions, any lesions that are ≥2 cm, or lesions that have high risk features under EUS. Annual surveillance is recommended for low risk GISTs. Neuroendocrine tumours (NET) , meanwhile, has higher malignant potentials. Some investigators advocate resecting all visible lesions. The minimal approach should be to resect tumors ≥1 cm in diameter. NET require surveillance similar if not more stringent than GIST.

Endoscopic mucosal forceps biopsy is the standard procedures for establishing diagnoses in patients with GI tumors. However, the false negative rate of endoscopic mucosal forceps biopsy can be as high as 50%. Possible reasons for this false negative rate include infiltrative and stenotic diseases as well as lesions in submucosal locations, such as lymphoma.

Because of their subepithelial location, biopsies with endoscopic forceps often fail to provide diagnostic tissues. Thus, further imaging and sampling techniques (often with EUS) often are used to characterize these lesions especially in large lesions.

Study objectives:

1. Primary Objectives:

   Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.
2. Secondary objectives:

Determining the real predominance of sub-epithelial lesions considering sex and age differences.

Investigating the geographic distribution in relation to the diagnosis of the lesions.

Detecting the commonest sites for the sub-epithelial lesions. Recording the symptomology related to each type.

Eligibility criteria: Inclusion Criteria:

1. Any patient with detected sub-epithelial lesion during upper endoscopy either symptomatized or accidently discovered.
2. Patients diagnosed by EUS, CT scan or surgically removed lesions.

Exclusion Criteria:

1. Patients missing follow up to reach a sure diagnosis for the lesions.
2. Patients unfit for endoscopic procedures.

Primary outcomes:
measure: Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.
timeFrame: 6 months
Secondary outcomes:
measure: characterization of SEL in Egypt
timeFrame: one year
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
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