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临床试验/NCT01742377
NCT01742377已完成不适用

i-Scan Endoscopy in the Detection of Minimal Change Esophagitis in Dyspeptic Patients With or Without Gastroesophageal Reflux Disease by Gerd Q Questionnaire and by 24 Hour pH Monitoring.

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
174
试验地点
1
主要终点
Evidence of minimal change erosions detected by i-scan endoscopy.

研究概览

简要总结

The purpose of this study to assess efficacy of SE endoscopy in the detection of MCE in dyspeptic patients with or without GERD diagnosed by GerdQ or by endoscopy + PHM and in normal volunteers.

详细描述

Background: The association of minimal change esophagitis (MCE) with gastroesophageal reflux (GERD) is controversy. High resolution endoscopy may improve the detection of minimal change lesion (MCL). i- Scan endoscopy (SE) provides high resolution images with modulation of images for a specific purpose.

Methods. All dyspeptic patients with or without GERD symptoms scheduled for endoscopy were recruited from February 2010 till July 2014. All completed the validated Thai version of GerdQ then underwent endoscopy. Forty normal volunteers were recruited for endoscopy and PHM test. The esophagus was examined by HD and SE with the TE-e mode sequentially. The captured images were independently evaluated for MCL (punctate erythema (PE), minute erosion (ME) and triangular lesion with elongated pit (EP) by three endoscopists. The agreement of > 2 endoscopists was accepted as a final result. All had PHM within 1 week after the endoscopy. GERD was diagnosed by LA grade A-D esophagitis and/or PHM with acid exposure time > the upper limit of volunteer and/or positive symptom index and/or positive Symptom Association Probability. MCE was diagnosed when PE, ME or EP or the combination of these were present.

The 40 normal volunteers were recruited for performing pH monitoring. The PHM data of 40 volunteers were analyzed to set the upper normal limit of total acid exposure time in our population. The mean + 2SD of total acid exposure time of volunteers was 1.9%.

Definition. GerdQ. The Thai version of GerdQ was translated from the English version. The contents of the GerdQ were tested by back translation from Thai to English by 5 personnel who are fluent in English and all showed the consistent contents. The reliability of the GerdQ was validated in 22 volunteers completing the questionnaire twice with 3 hours in between and showed no significant difference of the mean score (5.14+ 2.34 vs 6.23+ 1.57, p=0.07) and the number of subjects with GERD diagnosed by the GerdQ (2 vs 5, Fisher's extact test, p=0.21) .

GERD is diagnosed when total acid exposure time is more than 2% or positive symptom index (SI) or positive symptom association probability ( SAP ) or endoscopy revealed LA erosive esophagitis > grade A.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Patients with one or more of the following symptoms namely epigastric pain or discomfort, postprandial fullness and early satiety with or without symptoms suggesting GERD
  • Patients able to give informed consent

排除标准

  • Patients with significant weight loss.
  • Patients with hematemesis, melena ,dysphagia, intractable vomiting , palpable abdominal mass.
  • Patients with history of documented peptic ulcer , gastric surgery , gastric cancer.
  • Patients with symptoms compatible with irritable bowel syndrome, hepatobiliary tract disease.
  • Patients with severe concomitant medical conditions, pregnant woman or continuous usage of steroids or NSIADS in the preceding 1 month before entry to the study.

结局指标

主要结局

Evidence of minimal change erosions detected by i-scan endoscopy.

时间窗: within day of endoscopy

Minimal change lesions (MCL) included punctate erythema (PE), minute erosion (ME) and triangular lesion with elongated pit (TLE).

次要结局

  • Number of patients with dyspepsia are diagnosed gastroesophageal reflux disease by Gerd Q.(within the first 7 days after endoscopy)
  • Number of patients with dyspepsia are confirmed with GERD(within the first 7 days after endoscopy)
  • Total acid exposure in normal volunteers(1 day)

研究者

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

Nisa Netinatsunton

NKC Institute of Gastrornterology and Hepatology

Prince of Songkla University

研究点 (1)

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