Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)

Endogastric Solutions

Status: Completed

Conditions: Hiatal Hernia; Gastroesophageal Reflux Disease

Treatments: Procedure: Transoral Incisionless Fundoplication (TIF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01110811

D2009-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

TIF procedure

Active Comparator group

Description:

Transoral Incisionless Fundoplication (TIF)

Treatment:

Procedure: Transoral Incisionless Fundoplication (TIF)

Sham procedure

Sham Comparator group

Description:

The intervention on the Sham procedure consisted of an upper gastrointestinal endoscopy, or EGD.(esophagogastricduodenoscopy).

Treatment:

Procedure: Transoral Incisionless Fundoplication (TIF)