Magnified Intelligence Chromoendoscopy Plus Probe-based Confocal Laser Endomicroscopy for Gastric Intestinal Metaplasia Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- The feasibility of confocal endomicroscope in diagnose gastric intestinal metaplasia
研究概览
简要总结
Magnified intelligence chromoendoscopy (FICE) plus probe-based confocal laser endomicroscopy (pCLE) for Gastric Intestinal Metaplasia (GIM) diagnosis: a feasibility trial
Research Question:
Is confocal endomicroscope feasible to diagnose gastric intestinal metaplasia?
Objective:
To evaluate the feasibility of confocal endomicroscope in diagnose gastric intestinal metaplasia.
Hypothesis:
Confocal endomicreosocpe can provide the accurate diagnosis of gastric intestinal metaplasia.
Research design:
Diagnostic study
Sample size:
The investigators follow the population in recent study from Imraporn et al.: Validity of magnify NBI for gastric intestinal metaplasia targeted biopsy (N= 50)
Data analysis:
Confocal Barrett's esophagus classification was used to evaluate agreement of confocal endomicroscopic finding in gastric intestinal metaplasia. The accuracy of new criteria for GIM by confocal endomicroscope was evaluated in relation to pathological report, a gold standard for diagnosis, and reported as sensitivity, specificity, positive predictive value, negative predictive value and accuracy of these criteria.
Expected Benefit and Application:
The feasibility of confocal endomicroscopy for diagnosis gastric intestinal metaplasia in order to improve the quality of GIM/dysplasia/early gastric cancer detection and then decrease the mortality rate from gastric cancer in the future.
详细描述
Background and Rationale:
Gastric cancer is the second leading cause of cancer related death in the world in recently data. The incidence and mortality rate is predominant in East Asia. Usually, gastric cancer is asymptomatic in early stage; therefore; most patients is in the advanced stage and incurable at diagnosis. The pathogenesis of intestinal type gastric cancer is sequential and multistep pathway. Moreover, the direction of pathway is irreversible beyond dysplasia. The equipment and/or procedure which can detect gastric dysplasia are very beneficial.
The recent study, Imraporn B et al., showed that narrow-banded imaging with magnification (NBI-ME) had a better sensitivity for gastric intestinal metaplasia (GIM) detection than a standard white light endoscopy (73% VS. 13%) and could detect two early gastric cancer from tissue pathology in 1-year follow-up cohort study. However, NBI-ME cannot differentiate among GIM, dysplasia and gastric cancer.
Confocal endomicroscope is a powerful instrument for performing high-resolution (x1,000 time) imaging to enable real-time histology and/or optical biopsy at the time of endoscopic examination(in vivo histology).Fluorescein, is a slightly acidic and hydrophilic dye, will be used as staining substance via IV administration. The fluorescein established a stable distribution throughout surface epithelial cells, which is regular columnar epithelium with round gland openings and cobblestone pattern; the connective tissue matrix of lamina propria; blood vessels, which are regular shape visible in the deeper mucosa; and red blood cells.It is not highly miscible with mucins, hence, mucins in goblet cells, which indicated GIM, will appear dark.
Because GIM is characterized by the diminutive lesions or microscopic abnormalities amidst large fields of diffuse disease, biopsy targeting and adequate sampling can be difficult and time consuming. Therefore, the instant resection with confocal microendoscope is not possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 year-old
- •All patients were diagnosed GIM in the past 2 years.
- •All patients have to sign the consent form
排除标准
- •Previous gastric surgery including gastrectomy and bypass surgery
- •Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants
- •History of fluorescein allergy
结局指标
主要结局
The feasibility of confocal endomicroscope in diagnose gastric intestinal metaplasia
时间窗: Up to 2 years
If GIM can be detected properly, early gastric cancer(EGC) will be in early recognition. EGC can be cured by endoscopic resection and then the mortality rate from gastric cancer will be decrease.
次要结局
未报告次要终点
研究者
Rapat Pittayanon, MD
Principle investigator
King Chulalongkorn Memorial Hospital