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

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622098
• Other study ID #: 135/2020
• Status: Recruiting
• Start date: November 18, 2020
• Est. completion date: January 2022

Study information

• Verified date: November 2020
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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According to the Korea EUS Study Group (unpublished data), the prevalence of gastric SETs, detected routine esophagogastroduodenoscopy, in Korea is 3.1%.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2022
• Est. primary completion date: December 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Duodenal Neoplasms
• Esophageal Neoplasms
• Gastric Neoplasm
• Neoplasms
• Stomach Neoplasms

Intervention

Procedure:
• Endoscopic ultrasound
this is an endoscopic procedure for the assessment of the lesions, the following will be recorded: the tumor location, layer of origin, maximal diameter, regularity of extraluminal border, echopattern, presence of cystic spaces or echogenic foci.

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (5)

Lead Sponsor	Collaborator
Kafrelsheikh University	Al-Azhar University, Assiut University, Mansoura University Hospital, Menoufia University

Country where clinical trial is conducted

Egypt, 

References & Publications (16)

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 — View Citation

Delle Fave G, O'Toole D, Sundin A, Taal B, Ferolla P, Ramage JK, Ferone D, Ito T, Weber W, Zheng-Pei Z, De Herder WW, Pascher A, Ruszniewski P; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Gastroduodenal Neuroendocrine N — View Citation

Demetri GD, von Mehren M, Antonescu CR, DeMatteo RP, Ganjoo KN, Maki RG, Pisters PW, Raut CP, Riedel RF, Schuetze S, Sundar HM, Trent JC, Wayne JD. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl C — View Citation

Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210 — View Citation

Hedenbro JL, Ekelund M, Wetterberg P. Endoscopic diagnosis of submucosal gastric lesions. The results after routine endoscopy. Surg Endosc. 1991;5(1):20-3. — View Citation

Hwang JH, Rulyak SD, Kimmey MB; American Gastroenterological Association Institute. American Gastroenterological Association Institute technical review on the management of gastric subepithelial masses. Gastroenterology. 2006 Jun;130(7):2217-28. Review. — View Citation

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

Nishida T, Kawai N, Yamaguchi S, Nishida Y. Submucosal tumors: comprehensive guide for the diagnosis and therapy of gastrointestinal submucosal tumors. Dig Endosc. 2013 Sep;25(5):479-89. doi: 10.1111/den.12149. Epub 2013 Jul 31. Review. — View Citation

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/s0026 — View Citation

Palazzo L, Landi B, Cellier C, Cuillerier E, Roseau G, Barbier JP. Endosonographic features predictive of benign and malignant gastrointestinal stromal cell tumours. Gut. 2000 Jan;46(1):88-92. — View Citation

Papanikolaou IS, Triantafyllou K, Kourikou A, Rösch T. Endoscopic ultrasonography for gastric submucosal lesions. World J Gastrointest Endosc. 2011 May 16;3(5):86-94. doi: 10.4253/wjge.v3.i5.86. — View Citation

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. — View Citation

Polkowski M. Endoscopic ultrasound and endoscopic ultrasound-guided fine-needle biopsy for the diagnosis of malignant submucosal tumors. Endoscopy. 2005 Jul;37(7):635-45. Review. — View Citation

Ramage JK, De Herder WW, Delle Fave G, Ferolla P, Ferone D, Ito T, Ruszniewski P, Sundin A, Weber W, Zheng-Pei Z, Taal B, Pascher A; Vienna Consensus Conference participants. ENETS Consensus Guidelines Update for Colorectal Neuroendocrine Neoplasms. Neuro — View Citation

Standards of Practice Committee, Faulx AL, Kothari S, Acosta RD, Agrawal D, Bruining DH, Chandrasekhara V, Eloubeidi MA, Fanelli RD, Gurudu SR, Khashab MA, Lightdale JR, Muthusamy VR, Shaukat A, Qumseya BJ, Wang A, Wani SB, Yang J, DeWitt JM. The role of — View Citation

Wiech T, Walch A, Werner M. Histopathological classification of nonneoplastic and neoplastic gastrointestinal submucosal lesions. Endoscopy. 2005 Jul;37(7):630-4. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.	prevalence rate	6 months
Secondary	characterization of SEL in Egypt	correlation to demographic data	one year