Evaluation of the Safety and Effectiveness of Tailored Transoral Incisionless Fundoplication (TIF) Using EsophyX for the Treatment of GERD
Summary
Objectives of the Study:
The primary objective of this study is to evaluate the relative merits, safety and effectiveness of the tailored TIF2 procedure in treating GERD patients who have persistent GERD symptoms despite PPI therapy.
The secondary objective of the study is to evaluate the effectiveness of the tailored TIF procedure in restoring the antireflux barrier and eliminating GE reflux.
Type of Study:
Prospective, non-randomized, uncontrolled Study Duration 12 months Number of Patients 20
Inclusion Criteria:
Age 18-70 years, on daily PPIs for > 6 months, persistent GERD symptoms despite PPI therapy, anatomic disruption of the gastroesophageal valve to a Hill Grade II-III, evidence of one of the following while on PPI therapy: (1) erosive esophagitis (erosions or ulcerations during endoscopy); (2) abnormal ambulatory pH study; or (3) biopsy confirmed changes characteristic of reflux esophagitis; acceptable esophageal motility (by either manometry or video esophagogram), hiatal hernia no larger than 2 cm, patient willing to cooperate with post-operative dietary recommendations and assessment tests, signed informed consent
Exclusion Criteria:
BMI > 40, hiatal hernia > 2 cm, esophagitis grade D, esophageal ulcer, fixed esophageal stricture, gastric motility disorders, previous splenectomy, pregnancy (female), immunosuppression, ASA > 2, portal hypertension and/or varices, history of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis, active gastro-duodenal ulcer disease, gastric outlet obstruction or stenosis, gastroparesis or delayed gastric emptying, coagulation disorders
Interventions:
Treatment: Tailored transoral incisionless fundoplication (TIF2) using EsophyX system with SerosaFuse fasteners (EndoGastric Solutions, Inc., Redmond, WA, USA)
Evaluation Criteria:
Primary Outcome Measure 24 hour pH impedance study: change in Johnson DeMeester scores; GERD-HRQOL scores Secondary Outcome Measures PPI usage, GERD symptoms at 6 and 12 months vs. baseline off PPI's, total number of reflux episodes, and Symptom Association Probability while off PPI.
Safety: Adverse events will be mapped to standard terms and reported.
Study Design
Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Gastroesophageal Reflux Disease (GERD)
Intervention
EsophyX™ system with SerosaFuse fasteners
Location
CAMIS, Royal Alexandra Hospital
Edmonton
Alberta
Canada
T5H 3V9
Status
Suspended
Source
University of Alberta
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01025739
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bile Reflux
Retrograde bile flow. Reflux of bile can be from the duodenum to the stomach (DUODENOGASTRIC REFLUX); to the esophagus (GASTROESOPHAGEAL REFLUX); or to the PANCREAS.
Eosinophilic Esophagitis
Chronic ESOPHAGITIS characterized by esophageal mucosal EOSINOPHILIA. It is diagnosed when an increase in EOSINOPHILS are present over the entire esophagus. The reflux symptoms fail to respond to PROTON PUMP INHIBITORS treatment, unlike in GASTROESOPHAGEAL REFLUX DISEASE. The symptoms are associated with IgE-mediated hypersensitivity to food or inhalant allergens.
Cisapride
A substituted benzamide used for its prokinetic properties. It is used in the management of gastroesophageal reflux disease, functional dyspepsia, and other disorders associated with impaired gastrointestinal motility. (Martindale The Extra Pharmacopoeia, 31st ed)
Regurgitation, Gastric
GASTROESOPHAGEAL REFLUX wherein the retrograde flow passes through the UPPER ESOPHAGEAL SPHINCTER
Esophageal Ph Monitoring
Analysis of the HYDROGEN ION CONCENTRATION in the lumen of the ESOPHAGUS. It is used to record the pattern, frequency, and duration of GASTROESOPHAGEAL REFLUX.
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PubMed Articles
BACKGROUND: Several devices have been developed to create an antireflux barrier endoscopically for the treatment of gastroesophageal reflux disease. All have failed to provide long-term symptom relief...
INTRODUCTION: Transoral incisionless fundoplication (TIF) with the EsophyX(™) device is reported to be effective for creating a continent gastroesophageal valve and for good fu...
Gastroesophageal reflux disease in children.
Reflux of gastric contents is common in young infants but usually self-limiting and not pathological. Gastroesophageal reflux disease refers to persistent reflux due to pathological factors that resul...
Laparoscopic Nissen fundoplication after failed EsophyX((R)) fundoplication.
BACKGROUND:: Reflux control may be ineffective in a substantial number of patients after endoluminal EsophyX((R)) fundoplication for gastro-oesophageal reflux disease. Subsequent laparoscopic Nissen f...
INTRODUCTION: We studied the inter-relationships of endoscopic findings around the gastroesophageal junction in patients with symptomatic gastroesophageal reflux. METHODS: Data were collected with reg...
