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临床试验/NCT06269380
NCT06269380已完成不适用

Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy: A Retrospective Cohort Study

Sisli Hamidiye Etfal Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 671 人开始时间: 2024年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
671
试验地点
2
主要终点
Rate of abnormal histopathologic findings

研究概览

简要总结

Esophagogastroduodenoscopy (EGD) is commonly performed in patients presenting with abdominal pain and dyspeptic symptoms, serving as a valuable diagnostic and therapeutic tool. While various methods are available for biopsy sampling when mucosal pathology is observed during EGD, the practice of obtaining biopsies from endoscopically normal mucosa remains controversial. Although there is literature suggesting that routine biopsies from the antrum and duodenum for surveillance purposes increase costs, pathological findings can sometimes be detected in areas that appear normal on mucosal examination, leading to potential changes in treatment approach if biopsies are obtained.

In this study, a retrospective evaluation of the prevalence of various pathologies detected in biopsies obtained from endoscopically normal mucosa in patients who underwent EGD was reported as normal.

详细描述

Esophagogastroduodenoscopy (EGD) is a commonly used diagnostic tool in upper gastrointestinal system diseases. Its widespread use is facilitated by its minimally invasive nature, the possibility of therapeutic procedures, low complication rates, and broad applicability. Although there are numerous guidelines regarding approaches to endoscopic pathologies and diseases detected during esophagogastroduodenoscopy, the necessity of biopsy sampling from mucosal areas that are endoscopically normal remains controversial.

In this study, patients aged between 18 and 95 who underwent EGD at the Sisli Hamidiye Etfal Training and Research Hospital Surgical Endoscopy Unit between 2021 and 2023, with no pathology detected during the endoscopic examination and who underwent biopsy sampling, will be evaluated. History of upper gastrointestinal surgery, detection of the endoscopic pathology, and not having biopsy sampling will be considered as exclusion criteria. The rate of detection of histopathological findings in the obtained biopsies, severity and activity of gastritis, rate and density of Helicobacter pylori detection, and rate and extent of intestinal metaplasia will be evaluated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18-95
  • Endoscopically normal esophagogastroduodenoscopy
  • Sampling biopsies must be obtained

排除标准

  • History of upper gastrointestinal surgery
  • Abnormal endoscopic findings such as gastritis, ulcer, hiatal hernia, pyloric deformity, alkaline reflux
  • Not having biopsy

研究组 & 干预措施

Normal esophagogastroduodenoscopy

Experimental

Patients with normal esophagogastroduodenoscopic findings and biopsy samples were obtained.

干预措施: Esophagogastroduodenoscopy (Procedure)

Normal esophagogastroduodenoscopy

Experimental

Patients with normal esophagogastroduodenoscopic findings and biopsy samples were obtained.

干预措施: Endoscopic biopsy sampling (Procedure)

结局指标

主要结局

Rate of abnormal histopathologic findings

时间窗: 2 week after esophagogastroduodenoscopy

Rate of abnormal histopathologic findings in patients with normal esophagogastroduodenoscopy and sampling biopsies obtained

次要结局

  • Rate of intestinal metaplasia(2 week after esophagogastroduodenoscopy)
  • Rates of gastritis severity and activity(2 week after esophagogastroduodenoscopy)
  • Rate of Helicobacter Pylori positivity(2 week after esophagogastroduodenoscopy)

研究者

发起方
Sisli Hamidiye Etfal Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burak Dincer

Principal investigator

Sisli Hamidiye Etfal Training and Research Hospital

研究点 (2)

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