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临床试验/NCT07407296
NCT07407296
尚未招募
不适用

Multimodal Endoscopic Ultrasound in the Evaluation of the Nature of Indeterminate Upper Gastrointestinal Wall Thickening

Assiut University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2026年2月1日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
43
试验地点
1
主要终点
Diagnostic accuracy of multimodal EUS

概览

简要总结

Multimodal endoscopic ultrasound can help to differentiate between benign (non-cancerous) and malignant (cancerous) causes of thickening of the upper digestive tract wall.

The main questions this study aims to answer are:

How accurate is multimodal endoscopic ultrasound in identifying the cause of upper digestive tract wall thickening?

Can using several ultrasound techniques together improve diagnosis when standard tests are unclear?

Participants are adults who have upper digestive tract wall thickening seen on scans such as computed tomography (CT) or magnetic resonance imaging (MRI).

Participants will:

Undergo upper endoscopy followed by endoscopic ultrasound and tissue sample taken during the procedure when needed followed by using biopsy results or clinical follow-up to confirm the final diagnosis

This study aims to improve early and accurate diagnosis and help guide proper treatment decisions for people with unexplained upper digestive tract wall thickening.

详细描述

Upper gastrointestinal wall thickening (UGIT) refers to the abnormal increase in the thickness of the gastrointestinal wall, which can be observed in various clinical conditions, including both benign and malignant diseases (1).

Abnormal gastric wall thickening can be caused by a wide range of benign and malignant conditions, and expedient diagnosis is required to commence the appropriate treatment (2, 3).

Traditional diagnostic approaches for evaluating UGIT rely primarily on cross-sectional imaging techniques such as contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI). However, these modalities often lack sufficient spatial resolution to accurately characterize the individual layers of the gastrointestinal wall, particularly in cases of subtle mucosal or submucosal disease (4, 5).

Esophagogastroduodenoscopy (EGD) allows direct visualization of the mucosal surface and enables tissue sampling through conventional biopsies. Nevertheless, many pathological processes responsible for gastrointestinal wall thickening-such as gastric lymphoma, subepithelial tumors, linitis plastica, and infiltrative scirrhous carcinoma-originate in the deeper layers of the gastrointestinal wall (6).

EUS allows clear delineation of the gastrointestinal wall layers and surrounding structures. EUS-guided tissue acquisition using fine-needle biopsy (FNB) allows sampling of submucosal and muscular lesions that are inaccessible to conventional endoscopic biopsies (1).

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

  • Age ≥18 years
  • Patients with endoscopic or radiological (U/S, CT or MRI) evidence of upper GI wall thickening (esophagus, stomach, or duodenum) and defined based on established radiologic standards. A wall thickness by MSCT \>5 mm in the oesophagus and stomach and \>4 mm in the duodenum in accordance with accepted CT imaging criteria (4, 7).
  • Written informed consent provided.

排除标准

  • Patient refusal or inability to provide informed consent
  • Uncorrectable coagulation disorder e.g prothrombin concentration \<60%, INR \>1.5 or platelet count \<50,000/µL that cannot be corrected pre-procedure according to institutional guidelines.
  • Presence of contraindications for endoscopy/sedation.
  • Known diagnosis explaining wall thickening prior to EUS.

研究组 & 干预措施

Indeterminate Upper Gastrointestinal Wall Thickening

干预措施: Endoscopic ultrasound (Procedure)

结局指标

主要结局

Diagnostic accuracy of multimodal EUS

时间窗: one year

次要结局

  • EUS imaging patterns associated with various etiologies.(one year)
  • Incremental diagnostic value of elastography.(one year)
  • Diagnostic yield of EUS-guided tissue acquisition.(one year)

研究者

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

Taha Hussein Kawashty Abdelrahman

Assistent Lecturer at Tropical Medicine and Gastroenterology

Assiut University

研究点 (1)

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