Clinical Application of MUSE System for Ultrasound-guided Endoscopic Fundoplication for Gastro-esophageal Reflux Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
研究概览
简要总结
This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives:
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Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:
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effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores
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effect on the use and dosage of proton pump inhibitors (PPI)
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feasibility and safety of the endoluminal fundoplication procedure
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Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.
The study design includes the following phases:
*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
- 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
- 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
- Yearly clinical follow-up (up to 6 years):
PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
- •Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
- •Indication to surgical fundoplication
- •Patients available for a long-term follow-up
排除标准
- •Hiatal hernia ≥ 3 cm
- •Major esophageal motility disorder
- •Esophageal stenosis
- •Malignant neoplasia (except minor superficial skin neoplasm)
- •Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
- •Previous cardiac, thoracic or upper GI surgery
- •Pregnancy or breast feeding
结局指标
主要结局
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score
时间窗: change from baseline RSI at 6 years
RSI is a validate questionnaire to evaluate GERD-related extra- esophageal symptoms. The scale range is (0-45); the higher values represents worse outcomes.
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by changes in proton pump inhibitors (PPI) consumption
时间窗: change from baseline PPI consumption at 6 years
Gastric antisecretive therapy with proton pump inhibitors (PPI) is the gold standard for the treatment of GERD. This therapy is a chronic therapy with possible side effects. The endoscopic procedure under study aims to halved or discontinue the medical therapy
To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in GERD-HRQL (Gastro-esophageal Reflux Disease-Health Related quality of life) questionnaire score
时间窗: change from baseline GERD-HRQL at 6 years
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
次要结局
- To identify endoscopic factors predicting positive outcomes: changes in Hill's grade(change from baseline Hill's grade at 12 months)
- To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade(change from baseline esophagitis' grade at 12 months)
- To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size(change from baseline hiatal hernia size at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time)(change from baseline AET at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes(change from baseline number of weakly acid refluxes at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght(change from baseline LES lenght at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure)(change from baseline LES IRP at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score(change from baseline DeMeester score at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min)(change from baseline longest reflux episode at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time)(change from baseline BCT at 12 months)
- To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght(change from baseline Jobe's lenght at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance)(change from baseline MNBI at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in number of refluxes greater than 5 minutes(change from baseline number of refluxes greater than 5 minutes at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes(change from baseline number of total refluxes at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes(change from baseline number of acid refluxes at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral)(change from baseline DCI at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves(change from baseline rate of peristaltic waves at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes(change from baseline number of not acid refluxes at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes(change from baseline number of proximal refluxes at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves)(change from baseline PSPW at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure(change from baseline LES basal pressure at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves(change from baseline rate of weak waves at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves(change from baseline rate of fragmented waves at 12 months)
- To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves(change from baseline rate of failed waves at 12 months)
研究者
Pier Alberto Testoni
Professor
IRCCS San Raffaele