Gastroesophageal Reflux Disease, Hiatal Hernia
Conditions
Keywords
GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent
Brief summary
The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.
Detailed description
Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure). Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.
Interventions
PROCEDURETransoral Incisionless Fundoplication (TIF)
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.
Sponsors
EndoGastric Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years * On daily PPIs for \> 6 months * Documented PPI dependency * Persistent GERD symptoms without PPI therapy during the titration phase of the study * Evidence of two or more of the following while off PPI therapy (\> 10 days): * Erosive esophagitis (Los Angeles grade A-C) * Abnormal ambulatory pH study * Moderate to severe GERD symptoms * Normal or near normal esophageal motility (by manometry) * Patient willing to cooperate with post-operative dietary recommendations and assessment tests * Signed informed consent
Exclusion criteria
* BMI \> 35 * Hiatal hernia \> 3 cm * Esophagitis LA grade D * Esophageal ulcer * Esophageal stricture * Barretts esophagus (Prague: C\>1, M\>2) * Esophageal motility disorder * Severe gastric paralysis * Pregnancy or plans for pregnancy in the next 12 months * 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 * Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment * Coagulation disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients in clinical remission | at 6 month follow-up | Fifty nine per cent of patients remained in clinical remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in symptoms | at 6 moths follow-up | GSRS score improved from 14 (range 10-21) to 10 (range 6-19) with P = 0.004. |
| Normalized esophageal acid exposure | at 6 months follow-up | Sixty nine per cent of patients (69%) in TIF surgical arm normalized esophageal acid exposure. |
| Healed reflux esophagitis | at 6 months follow-up | In 80% of patients healing of esophagitis was observed |
Countries
Belgium, France, Sweden
Outcome results
None listed