Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

This retrospective, open-label, post-market study evaluates the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States, in clinical routine practice, as standard of care.

• Transoral Incisionless Fundoplication (Device), also known as TIF: Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless Fundoplication 2.0 technique iteration (TIF2.0) protocol.

Primary outcomes

• Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination [median 7 months (range 5-17 months)]: Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of <18) and Reflux Symptom Index (RSI measures atypical laryngopharyngeal (LPR) symptoms, scale 0-5 for each of 9 questions with maximum of 45 with a normality threshold of < or = 13) questionnaires) at the follow-up.

Secondary outcomes

• Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs) [median 7 months (range 5-17 months)]: The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication.
• Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use [median 7 months (range 5-17 months)]: Patients reporting complete discontinuation of daily PPI use will be considered clinically significant.
• Number of Participants With Healing of Reflux Esophagitis [median 7 months (range 5-17 months)]: One LA grade reduction will be considered clinically significant. LA grades are A, B, C, D, with A being the least severe esophagitis. No grade assigned is considered "normal", i.e. no esophagitis reported.
• Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up [median 7 months (range 5-17 months)]: Measurement obtained by study investigator, under endoscopic visualization using cm markings on the endoscope. Outcome measure assesses if hiatal hernia that was present at baseline and reduced (size reduction to < 1 cm is considered clinically significant) during TIF procedure, has remained reduced at the post-TIF follow up exam.
• Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes [median 7 months (range 5-17 months)]: Esophageal acid exposure will be measured objectively by 48-hour Bravo Potential of Hydrogen (pH) or 24-hour impedance/pH testing at the follow-up (where pH testing is available). Normalization of esophageal acid exposure will be defined by total time pH< 4 for ≤ 6% of 24-hour or for ≤ 5.3% of 48-hour monitoring period. The number of reflux episodes of ≤ 44 per each 24-hour period will be considered normal.

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* Age 18-85 years
* Have undergone the TIF procedure within the past 2 years
* History of daily proton pump inhibitor (PPI) use for >6 months
* Proven gastroesophageal reflux by either endoscopy, ambulatory potential of hydrogen (pH) or moderate to severe symptoms on or off PPIs
* Deteriorated gastroesophageal junction (Hill grade II or III)
* Availability for a follow-up visit at 6,12 or 24 months
* Willingly and cognitively signed informed consent

Exclusion Criteria:

* Procedure not completed or performed following a non-standardized TIF protocol
* Subjects suffering from other gastrointestinal (GI) conditions such as dyspepsia, celiac disease, Irritable bowel syndrome (IBS) or Crohn's disease
* Pregnancy
* Enrollment in another device or drug study that may confound the results

Participant flow

Outcome results

• Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination (Primary), Count of participants, Participants: Transoral Incisionless Fundoplication 88
• Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs) (Secondary), Count of participants, Participants: Transoral Incisionless Fundoplication 0
• Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use (Secondary), Count of participants, Participants: Transoral Incisionless Fundoplication 102
• Number of Participants With Healing of Reflux Esophagitis (Secondary), Count of participants, Participants: Transoral Incisionless Fundoplication 25
• Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up (Secondary), Count of participants, Participants: Transoral Incisionless Fundoplication 33
• Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes (Secondary)

Adverse events

Time frame: This is a retrospective study. TIF procedures were performed from November 2008 through December 2009. The study enrolled patients and collected post-TIF follow up visits in 2010. Adverse event data was collected from day of TIF procedure through final follow-up visit.

• William Barnes, MD MBA FACS, Principal investigator, Livingston Hospital and Healthcare Services Inc, CAH