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临床试验/NCT04622098
NCT04622098Unknown不适用

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

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2020年11月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
Estimating the prevalence and types of sub-epithelial lesions among patients undergoing EGDs in Egypt.

研究概览

简要总结

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.

详细描述

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According to the Korea EUS Study Group (unpublished data), the prevalence of gastric SETs, detected routine esophagogastroduodenoscopy, in Korea is 3.1%.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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 6 months

prevalence rate

次要结局

  • characterization of SEL in Egypt(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariam Salah Zaghloul

Doctor

Kafrelsheikh University

研究点 (1)

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