跳至主要内容
临床试验/CTRI/2024/09/073823
CTRI/2024/09/073823尚未招募不适用

Eosinophilic esophagitis-Indian scenario.

未提供1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2024年9月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
101
试验地点
1
主要终点
To determine the prevalence of eosinophilic esophagitis using aa standardized biopsy

研究概览

简要总结

After obtaining written informed consent and checking for exclusion criteria, patients with symptoms suggestive of GERD or esophageal dysfunction will be recruited for endoscopy.

Information regarding relevant history, physical examination, demographic and laboratory parameters will be entered in a preformatted data sheet.

All patients will undergo upper endoscopy. 4 biopsies from each quadrant will be taken 14cms and 4cms above the esophagogastric junctions regardless of macroscopic appearance using standard biopsy forceps.

Biopsies will be stored in 10% formalin for pathological examination.

The average eosinophil count in high power magnification will be taken for diagnosis.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients above 18 years of age.
  • Symptoms suggestive of eosinophilic esophagitis like Heartburn, chronic reflux, dysphagia, food impaction and esophageal chest pain.
  • Any endoscopic evidence of eosinophilic esophagitis which include linear furrows, pinpoint exudates, feline rings, stricture, fixed rings, or esophagitis.

排除标准

  • Cardio-respiratory, renal comorbidities precluding diagnostic endoscopy.
  • Patients with history of drug-induced esophagitis.
  • Crohn’s disease Esophageal malignancy Intake of PPI within last 4 weeks.

结局指标

主要结局

To determine the prevalence of eosinophilic esophagitis using aa standardized biopsy

时间窗: 6 months

protocol.

时间窗: 6 months

次要结局

  • To see for prevalence of eosinophilic esophagitis in GERD, Predictive factors for(eosinophilic esophagitis like atopy.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Ganesh Bhat

Manipal Academy of Higher Education

研究点 (1)

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