Endoscopic Fundoplication With MUSE System
Study Details
Study Description
Brief Summary
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
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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
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12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
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Yearly clinical follow-up (up to 6 years):
PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- 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 [change from baseline GERD-HRQL at 6 months]
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
- 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 [change from baseline GERD-HRQL at 12 months]
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
- 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 [change from baseline GERD-HRQL at 24 months]
GERD-HRQL is a validate questionnaire to evaluate GERD-related esophageal symptoms. The scale range is (0-50); the higher values represents worse outcomes.
- 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 [change from baseline GERD-HRQL at 3 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.
- 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 [change from baseline GERD-HRQL at 4 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.
- 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 [change from baseline GERD-HRQL at 5 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.
- 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 [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.
- To evaluate clinical efficacy of endoscopic fundoplication with MUSE as assessed by change in RSI (Reflux Symptom Index) questionnaire score [change from baseline RSI at 6 months]
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 change in RSI (Reflux Symptom Index) questionnaire score [change from baseline RSI at 12 months]
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 change in RSI (Reflux Symptom Index) questionnaire score [change from baseline RSI at 24 months]
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 change in RSI (Reflux Symptom Index) questionnaire score [change from baseline RSI at 3 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 change in RSI (Reflux Symptom Index) questionnaire score [change from baseline RSI at 4 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 change in RSI (Reflux Symptom Index) questionnaire score [change from baseline RSI at 5 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 change in RSI (Reflux Symptom Index) questionnaire score [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 [change from baseline PPI consumption at 6 months]
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 changes in proton pump inhibitors (PPI) consumption [change from baseline PPI consumption at 12 months]
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 changes in proton pump inhibitors (PPI) consumption [change from baseline PPI consumption at 24 months]
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 changes in proton pump inhibitors (PPI) consumption [change from baseline PPI consumption at 3 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 changes in proton pump inhibitors (PPI) consumption [change from baseline PPI consumption at 4 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 changes in proton pump inhibitors (PPI) consumption [change from baseline PPI consumption at 5 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 changes in proton pump inhibitors (PPI) consumption [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
Secondary Outcome Measures
- To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [change from baseline hiatal hernia size at 6 months]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
- To identify endoscopic factors predicting positive outcomes: changes in hiatal hernia size [change from baseline hiatal hernia size at 12 months]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The size of a hiatal hernia is a parameter describing the continence characteristics of the sphincter neo-valve.
- To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [change from baseline Hill's grade at 6 months]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
- To identify endoscopic factors predicting positive outcomes: changes in Hill's grade [change from baseline Hill's grade at 12 months]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Hill's grade is a parameter describing the continence characteristics of the sphincter neo-valve. The Hill's grade range from I to IV; the higher grades represents worse outcomes (worse valve's continence).
- To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [change from baseline Jobe's lenght at 6 months]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
- To identify endoscopic factors predicting positive outcomes: changes in Jobe's lenght [change from baseline Jobe's lenght at 12 months]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The Jobe's lenght is a parameter describing the continence characteristics of the sphincter neo-valve.
- To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [change from baseline esophagitis' grade at 6 months]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.
- To identify endoscopic factors predicting positive outcomes: changes in esophagitis' grade [change from baseline esophagitis' grade at 12 months]
Endoscopic fundoplication with MUSE modifies the anatomy of the esophago-gastric junction to reduce the reflux of gastric contents into the esophagus. The presence of esophagitis and its grade, as defined by the Los Angeles classification, is a parameter of procedure's efficacy. The esophagitis grade range from A to D; the higher grades represents worse outcomes.
- To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [change from baseline DeMeester score at 6 months]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.
- To identify pathophysiological factors predicting positive outcomes: changes in DeMeester score [change from baseline DeMeester score at 12 months]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux. DeMeester score is a composite score which examined six variables (number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position). A score of >14.72 shows a pathological reflux. Higher values represent worse outcomes.
- To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [change from baseline AET at 6 months]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in AET (Acid Exposure Time) [change from baseline AET at 12 months]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min) [change from baseline longest reflux episode at 6 months]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in longest reflux episode (min) [change from baseline longest reflux episode at 12 months]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- 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 6 months]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- 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]
parameter detected by 24hours esophagel pH-metry. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes [change from baseline number of total refluxes at 6 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of total refluxes [change from baseline number of total refluxes at 12 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes [change from baseline number of acid refluxes at 6 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of acid refluxes [change from baseline number of acid refluxes at 12 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of weakly acid refluxes [change from baseline number of weakly acid refluxes at 6 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- 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]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of not acid refluxes [change from baseline number of not acid refluxes at 6 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- 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]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes [change from baseline number of proximal refluxes at 6 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in number of proximal refluxes [change from baseline number of proximal refluxes at 12 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance) [change from baseline MNBI at 6 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in MNBI (Mean Nocturnal Baseline Impedance) [change from baseline MNBI at 12 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves) [change from baseline PSPW at 6 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in PSPW (Post Swallow reflux-induced Peristaltic Waves) [change from baseline PSPW at 12 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time) [change from baseline BCT at 6 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in BCT (Bolus Clearance Time) [change from baseline BCT at 12 months]
parameter detected by 24hours esophagel impedance. pH-metric and impedance parameters are indicators of procedure effectiveness as able to quantify the presence of gastro-esophageal reflux.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure [change from baseline LES basal pressure at 6 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) basal pressure [change from baseline LES basal pressure at 12 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght [change from baseline LES lenght at 6 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) lenght [change from baseline LES lenght at 12 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in LES (Lower Esophageal Sphincter) IRP (Integrated Relaxation Pressure) [change from baseline LES IRP at 6 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- 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]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral) [change from baseline DCI at 6 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in DCI (Distal Contractile Integral) [change from baseline DCI at 12 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves [change from baseline rate of peristaltic waves at 6 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of peristaltic waves [change from baseline rate of peristaltic waves at 12 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves [change from baseline rate of weak waves at 6 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of weak waves [change from baseline rate of weak waves at 12 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves [change from baseline rate of fragmented waves at 6 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of fragmented waves [change from baseline rate of fragmented waves at 12 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves [change from baseline rate of failed waves at 6 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
- To identify pathophysiological factors predicting positive outcomes: changes in rate of failed waves [change from baseline rate of failed waves at 12 months]
parameter detected by High Resolution Esophageal Manometry (HRM). The manometric parameters describe the continence characteristics of the sphincter neo-valve and changes in esophageal motility after the intervention.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
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Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
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Indication to surgical fundoplication
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Patients available for a long-term follow-up
Exclusion Criteria:
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Hiatal hernia ≥ 3 cm
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Major esophageal motility disorder
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Esophageal stenosis
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Malignant neoplasia (except minor superficial skin neoplasm)
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Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
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Previous cardiac, thoracic or upper GI surgery
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BMI >40
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Pregnancy or breast feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pier Alberto Testoni | Milan | Italy | 20132 |
Sponsors and Collaborators
- IRCCS San Raffaele
Investigators
- Principal Investigator: Pier Alberto Testoni, Professor, San Raffaele Scientific Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MUSE/2015