Comparison of Two Methods for Endoscopic Biopsy to Detect Helicobacter Pylori
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- 2 Antrum biopsy diagnostic performance
研究概览
简要总结
Helicobacter pylori (H. pylori) infection represents one of the most common chronic infections that affect humans.Endoscopy must be performed to take biopsies for detection of Helicobacter pylori in patients with alarm symptoms. The Sydney Protocol is the recommended strategy that guarantees maximum diagnostic yield. This is a prospective uncontrolled cross-sectional clinical trial.
Endoscopy must be performed to take biopsies for detection of Helicobacter pylori in patients with epigastric pain, weight loss, iron-deficiency anemia, individuals with dyspepsia over 60 years of age or younger with alarm symptoms (weight loss, dysphagia, vomiting, gastrointestinal bleeding, among others).
The Sydney Protocol is the recommended strategy that guarantees maximum diagnostic yield. Histology is expensive since it requires time for biopsy processing and trained personnel for staining and interpretation but it provides additional information on the degree of inflammation and complications such as atrophic gastritis, intestinal metaplasia, and malignancy. The modified Sydney protocol includes two biopsies from the antrum, two from the body, and one form the incisura.
详细描述
The hypothesis is that the histopathological study of two biopsies obtained from the gastric antrum for the determination of Helicobacter pylori infection has a similar diagnostic yield compared to the gold standard (Sydney protocol). This is a prospective uncontrolled cross-sectional clinical trial.
Patients older than 18 years with a medical indication for performing upper gastrointestinal endoscopy for biopsy and detection of Helicobacter pylori infection in the period from january to May 2020.
A sample size of 67 patients was calculated using the diagnostic test comparison formula, in order to compare the sensitivity and specificity in patients with indications for a biopsy taken with the Sydney protocol from those taken only from the gastric antrum.
Expecting a sensitivity of 89% in the Sydney protocol With a Zα of 1.96 and a maximum amplitude of 7.5% (CI = 15), at least 67 study subjects are required with the two diagnostic tests.
Cold biopsies will be taken using an oval head clamp with a stiletto, 2.3 mm in diameter and 180 cm in length of the gastric mucosa with the current standardized method (Sydney protocol).
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
- 否
入选标准
- •Older than 18 years
- •Have a clinical file.
- •Medical indication for upper gastrointestinal endoscopy and biopsy to detect Helicobacter pylori
排除标准
- •Active gastrointestinal bleeding
- •Antibiotic use in the last 30 days
- •Hemodynamic instability
- •Platelets <50,000 K/µL
- •INR >1.5 or PT >50 sec
- •Having received eradication treatment for Helicobacter pylori previously.
- •History of gastric surgery
- •Pregnancy
结局指标
主要结局
2 Antrum biopsy diagnostic performance
时间窗: 7 days
To determine the diagnostic performance in the detection of Helicobacter pylori in biopsies taken only from the gastric antrum for the determination of the positive predictive value, the negative predictive value, and sensitivity and specificity.
次要结局
未报告次要终点
研究者
Dr. med. Hector Eloy Tamez Perez
Clinical professor
Hospital Universitario Dr. Jose E. Gonzalez