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

NCT04622098 | Unknown DMC

• 1 other identifier: 135/2020
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Neoplasms; Gastric Neoplasm; Duodenal Neoplasms

Keywords

sub-epithelial lesions; esophagogastrodudenoscopy; EUS FNA/FNB

Outcome Measures

Primary Outcomes (1)

• Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.

  prevalence rate

  6 months

Secondary Outcomes (1)

• characterization of SEL in Egypt

  one year

Study Arms (1)

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

Interventions

Endoscopic ultrasound PROCEDURE

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.

Also known as: CT

patients with SEL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kafrelsheikh University: lead
• Mansoura University Hospital: collaborator
• Menoufia University: collaborator
• Al-Azhar University: collaborator
• Assiut University: collaborator

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33565, Egypt

RECRUITING

Related Publications (16)

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• Park EY, Kim GH. Diagnosis of Gastric Subepithelial Tumors Using Endoscopic Ultrasonography or Abdominopelvic Computed Tomography: Which is Better? Clin Endosc. 2019 Nov;52(6):519-520. doi: 10.5946/ce.2019.188. Epub 2019 Nov 14. No abstract available.

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• Mathew, Madhu MD1; Mbachi, Chimezie MD1; Desai, Parth M. DO1; Salazar, Miguel MD2; Vohra, Ishaan MD1; Wang, Yuchen MD2; Gandhi, Seema MD3; Attar, Bashar M. MD, PhD1 2893 Epidemiology of Sub-Epithelial Gastrointestinal Lesions and Factors Influencing Their Tissue Yield by EUS Guided Sampling in a Predominantly African-American and Hispanic Population at a Tertiary Care County Hospital, The American Journal of Gastroenterology: October 2019 - Volume 114 - Issue - p S1584 doi: 10.14309/01.ajg.0000601104.52032.6f

  RESULT

• Okten RS, Kacar S, Kucukay F, Sasmaz N, Cumhur T. Gastric subepithelial masses: evaluation of multidetector CT (multiplanar reconstruction and virtual gastroscopy) versus endoscopic ultrasonography. Abdom Imaging. 2012 Aug;37(4):519-30. doi: 10.1007/s00261-011-9791-0.

  PMID: 21822967 RESULT

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  PMID: 26784901 RESULT

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  PMID: 10601061 RESULT

• ASGE Standards of Practice Committee; Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Adverse events associated with ERCP. Gastrointest Endosc. 2017 Jan;85(1):32-47. doi: 10.1016/j.gie.2016.06.051. Epub 2016 Aug 18. No abstract available.

  PMID: 27546389 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for routine laboratory inverstigations tissue sample from the SEL if indicated or gross excisional sample post surgery

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Duodenal Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Duodenal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 9, 2020
• Study Start: November 18, 2020
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: September 1, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)