What is the Physiologic and Clinical Relevance of Oesophagogastric Junction Distensibility? Studies Using Endo-Flip and 96 Hour Wireless pH System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Diagnostic reliability of prolonged wireless pH monitoring and comparison oesophago-gastric junction distensibility
研究概览
简要总结
Monitoring oesophageal pH provides a definitive diagnosis of patients with gastro-oesophageal reflux disease (GORD), especially those in whom the association between reflux and symptoms is uncertain and those under consideration for anti-reflux surgery. Standard ambulatory investigation is normally performed by naso-oesophageal catheter however this is associated with considerable discomfort and in turn altered behaviour which reduces reflux provoking activities. Furthermore results of catheter based ambulatory pH studies are compromised by the high variability of acid exposure in patients with suspected GORD.
Prolonging pH measurements by the catheter-free Bravo™ system from 24 to 48 and 96hrs significantly improves the consistency (reliability) and reproducibility of diagnoses based on oesophageal acid exposure, as well as the ability to associate acid reflux to symptom episodes. This improves diagnosis especially in those with intermittent symptoms.
However pH monitoring does not provide a direct assessment of the underlying pathophysiology. Incompetence of the oesophago-gastric junction (OGJ) related to disruption of its structure and function is considered to be the most important cause of GORD. A more relevant assessment of the reflux barrier may be its distensibility (i.e. the ease with which the OGJ is opened to allow retrograde passage of gastric contents); however this is not assessed by current clinical investigations.
Endo-FLIP (Crospon Medical Devices) is a new tool which assesses OGJ structure and function, and appears to provide relevant information regarding its distensibility and competence.
This study applies to using Endo-Flip to record OGJ distensibility and Bravo to record acid exposure and symptom association in patients with reflux symptoms. The variability of pH measurements and symptoms and diagnostic accuracy will be assessed over 96hrs. Endo-FLIP results will then be compared against Bravo. The outcome of post investigation therapy will then be compared with Endo-Flip and Bravo results to assess if baseline testing can predict the outcome of acid suppression therapy.
Study Hypothesis
- There is a positive, continuous association between OGJ distensibility measured by Endo-FLIP on % acid exposure assessed by prolonged Bravo pH monitoring
- The results of Endo-FLIP and prolonged Bravo predict treatment outcome of a trial of proton pump inhibitor therapy
详细描述
This is a single centre study of patients (n=60) referred for investigation of reflux symptoms. Each patient is investigated by Endo-FLIP™, endoscopy, and 96 hour Bravo™ pH monitoring off acid suppressant medication.
After calibration the Endo-FLIP catheter will be inserted orally or nasally until the liquid-filled compliant bag at the distal segment of the catheter (which houses 16 impedance sensors) straddles the OGJ. Stepwise bag distensions of 10, 20 and 30 ml will then be conducted and the associated intra-bag pressure measured. The Endo-FLIP display will allow real-time imaging of OGJ intra-luminal geometry during distension. Intra-bag pressure and CSA at the impedance planimetry segment best localized within the OGJ will be reported as mean ± SEM.
An endoscopy will then be performed to confirm the position of the squamo-columnar junction (SCJ). Images will be taken of the SCJ using standard white light and narrow band imaging. Then 2 x 2 biopsies from the SCJ and 2 cm proximally will be taken. In conclusion, the Bravo® delivery system will be passed orally with the patient lying in the left lateral decubitus position and the capsule will be deployed 6 cm proximal to the SCJ after 1 minute of suction to stabilize the position.
After 2 measurements for 48 hours (separated by a battery change) the patient will return the receiver for the final download and analysis. In addition to pH measurement and symptom documentation during the 96hr period, pepsin lateral flow tests (Technostics, Hull, UK) will be performed by collecting expectorated saliva on returning to the lab on day 2 and day 4. Patients will also be provided with two further kits to be used if and when they experience symptoms during the 4 day study.
The primary outcome assessment of oesophageal acid exposure will be percent time pH<4 over the measurement period (e.g. 24, 48 or 96h). Other parameters that will be analysed are the number of reflux events and the association of these events with symptoms recorded on the Bravo™ receiver. The presence or absence of pepsin in expectorated saliva will also be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written, fully informed consent to undergo mechanistic procedures: Endo-FLIP, endoscopy and biopsy, 4 day wireless pH monitoring by the Bravo system
- •All subjects should be off acid suppression medication (e.g. PPI, H2RA) for at least 5 days prior to endoscopy
排除标准
- •Significant gastrointestinal symptoms or disease other than reflux
- •Previous upper GI surgery or interventions such as oesophageal dilatations
- •Predominant symptoms of motility disorders, e.g. dysphagia
- •Presence of major oesophageal dysmotility on manometry, e.g. achalasia
- •Significant co-morbidity requiring ongoing treatment or investigation
- •Physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment/reduced mobility)
- •Pregnant at the time of enrolment
- •No haematological abnormalities (no anticoagulants)
- •No medications influencing gastrointestinal function within 3 days of the study.
结局指标
主要结局
Diagnostic reliability of prolonged wireless pH monitoring and comparison oesophago-gastric junction distensibility
时间窗: 1 year
1. To confirm improved diagnostic reliability and accuracy of prolonged pH measurement by the Bravo™ system in a large, prospective clinical trial 2. To confirm that there is a positive, continuous association between oesophago-gastric junction (OGJ) distensibility measured by Endo-FLIP on percentage acid exposure assessed by prolonged Bravo-pH monitoring
次要结局
- Prediction of treatment outcome with Endo-Flip and Bravo(2 years)