Clinical trial NCT01647958: The EndoGastric Solutions TEMPO Trial
Official title: Transoral Incisionless Fundoplication (TIF) Versus Medical Proton Pump Inhibitor (PPI) Management of Refractory Gastroesophageal Reflux Disease (GERD) Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: TEMPO
TIF
Transoral Incisionless Fundoplication
EsophyX System
refractory symptoms
proton pump inhibitors
EndoGastric Solutions
EGS
Acid Reflux
Heartburn
Regurgitation
Lead sponsor: EndoGastric Solutions
Sponsor class: INDUSTRY
First posted: 2012-07-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of Transoral Incisionless Fundoplication (TIF) performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic Gastroesophageal Reflux Disease (GERD) patients with refractory symptoms on Proton Pump Inhibitors (PPIs).

Detailed description: The objective of this study is to assess the efficacy and safety of TIF performed with EsophyX as compared to proton pump inhibitor (PPI) therapy for the treatment of chronic GERD patients with medically refractory GERD symptoms other than heartburn.

Primary hypothesis: TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at 6-month follow-up. Secondary hypotheses: TIF will be superior to PPIs in eliminating or significantly improving daily bothersome GERD symptoms and/or troublesome regurgitation, if present, at 12-, 24-, 36-, 48- and 60-month follow-up. The majority of surgical patients will have normalized or 50% improved esophageal acid exposure compared to baseline at 6-month follow-up. The majority of surgical patients will be completely off PPIs at 6-, 12-, 24-, 36-, 48- and 60-month follow-up compared to baseline. The majority of crossover patients will be completely off PPIs at 6-, 18-, 30-, 42- and 54-month follow-up compared to baseline. A statistically greater proportion of crossover patients treated with TIF will be free of daily bothersome symptom(s) or will experience clinically significant improvement at 6-, 18-, 30-, 42- and 54-month follow-up.

Eligibility criteria: Inclusion Criteria:

1. Age 18-80 years;
2. GERD for \> 1 year;
3. History of daily PPIs for \> 6 months;
4. At least daily bothersome medically refractory GERD symptom(s) other than heartburn on PPIs;
5. Hill grade I and II at gastroesophageal junction;
6. Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing;
7. Willingness to undergo pH testing;
8. Willingness to cooperate with the postoperative diet;
9. Availability for follow-up visits at 6, 12, 24, and 36 months;
10. Willingly and cognitively signed inform consent

Exclusion Criteria:

1. BMI \> 35 Hiatal hernia \> 2c m in axial height and \> 2 cm in greatest transverse dimension;
2. Esophagitis grade C and D;
3. Barrett's esophagus \> 2 cm;
4. Esophageal ulcer;
5. Fixed esophageal stricture or narrowing;
6. Portal hypertension and/or varices;
7. Active gastro-duodenal ulcer disease; Gastric outlet obstruction or stenosis;
8. Gastroparesis;
9. Coagulation disorders;
10. History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis;
11. Pregnancy or plans of pregnancy in the next 12 months;
12. Enrollment in another device or drug study that may confound the results

Primary outcomes:
measure: Number of Participants Reporting GERD (Gastroesophageal Reflux Disease) Symptom Elimination or Clinically Significant Improvement Evaluated by RSI (Reflux Symptom Index) and RDQ (Reflux Disease Questionnaire).
timeFrame: 6 months
measure: Number of Participants Reporting Elimination of Daily Troublesome Regurgitation Using a Validated Questionnaire for Assessment
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Complete PPI Discontinuation Assessed Using Validated Questionnaires and Participant-reported Discontinuation
timeFrame: 6 Months
measure: Number of Participants With Normalization of Esophageal Acid Exposure Assessed Using 48-hour pH Metry
timeFrame: 6 Months
measure: Number of Participants With Complete Healing or Reduction of Reflux Esophagitis, Assessed by EGD Using Los Angeles (LA) Grading
timeFrame: 6 months
Other outcomes:
measure: Number of Participants With Elimination of Daily Troublesome Heartburn Assessed Using a Validated Questionnaire
timeFrame: 6 months
Locations:
city: Redmond
country: United States
facility: EndoGastric Solutions
state: Washington
Study officials:
affiliation: Reston Surgical Associates
name: Karim Trad, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trad KS, Simoni G, Barnes WE, Shughoury AB, Raza M, Heise JA, Turgeon DG, Fox MA, Mavrelis PG. Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study. BMC Gastroenterol. 2014 Oct 6;14:174. doi: 10.1186/1471-230X-14-174.