Prevalence of Sub-epithelial Lesions Among Patients Undergoing EGDs in Egypt

August 30, 2021 updated by: Mariam Salah Zaghloul, Kafrelsheikh University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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According to the Korea EUS Study Group (unpublished data), the prevalence of gastric SETs, detected routine esophagogastroduodenoscopy, in Korea is 3.1%.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

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Kafrelsheikh
      • Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33565

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with SEL

Any patient with detected sub-epithelial lesion during upper endoscopy either symptomatized or accidently discovered.

Patients diagnosed by EUS, CT scan or surgically removed lesions.
Procedure: Endoscopic ultrasound

this is an endoscopic procedure for the assessment of the lesions, the following will be recorded:

  1. the tumor location,
  2. layer of origin,
  3. maximal diameter,
  4. regularity of extraluminal border,
  5. echopattern,
  6. presence of cystic spaces or echogenic foci.
Other Names:
  • CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.
Time Frame: 6 months
prevalence rate
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
characterization of SEL in Egypt
Time Frame: one year
correlation to demographic data
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Collaborators

Assiut University
Menoufia University
Al-Azhar University
Mansoura University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 135/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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