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GERD: Transoral Incisionless Fundoplication beats placebo

Elimination of troublesome regurgitation was achieved in a greater proportion of patients treated with transoral fundoplication than with omeprazole

The first-ever blinded, randomised, sham and placebo-controlled clinical study of the Transoral Incisionless Fundoplication (TIF) procedure has concluded that it is an effective treatment for patients with gastroesophageal reflux disease (GERD), especially for patients with persistent regurgitation despite proton pump inhibitor (PPI) therapy. The study, was published in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute.

“Despite therapy, patients with GERD often suffer from troublesome regurgitation, which impairs their quality of life,” said lead study author Dr John G Hunter from Oregon Health & Science University. “This study offers evidence that transoral fundoplication is effective in eliminating troublesome GERD symptoms, especially regurgitation, with a low failure rate and good safety profile for six months.”

Transoral fundoplication - an incisionless procedure that allows physicians to reshape the anti-reflux valve that prevents stomach acid and contents from flowing up into the oesophagus - may offer a new treatment option for these patients.

The EsophyX device (EndoGastric Solutions) was FDA cleared in 2007, and is commercially available in the US. Inserted through the patient's mouth with visual guidance from an endoscope, the EsophyX device is used to reconstruct the gastroesophageal valve (GEV) in order to restore its function as a barrier to prevent stomach acids from washing back up into the oesophagus. Performed entirely through the mouth without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical change to correct the underlying cause of GERD, another treatment option beyond traditional surgery.

Researchers performed a prospective, sham-controlled trial to determine if transoral fundoplication provided GERD patients with better relief of troublesome regurgitation, or the sensation of acid backing up into a patient’s throat or mouth, when compared to PPI therapy. The researchers randomly assigned 129 patients with troublesome regurgitation despite daily PPI use to transoral fundoplication using the EsophyX-2 device and six months of placebo, or a sham surgery and six months of once or twice daily omeprazole. Patients were then evaluated for six months.

Both groups of patients enrolled in the RESPECT study, and their caregivers, were blinded to therapy during follow-up which occurred at two, 12 and 26 weeks. At the six month follow-up, all patients were un-blinded and the sham control patients were given the opportunity to have a TIF procedure.

The primary endpoint in this study, elimination of troublesome regurgitation, was achieved in a greater proportion of patients treated with transoral fundoplication than with omeprazole: 67 percent vs. 45 percent. Further, a larger proportion of controls demonstrated no response at three months (36 percent) than patients who underwent transoral fundoplication (11 percent). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare.

"The data demonstrates that the TIF procedure is more effective than optimized PPI drugs at eliminating troublesome regurgitation in selected chronic GERD patients with hiatal hernia less than 2cm," added Hunter.

In addition, 77% of the TIF patients had healed their reflux oesophagitis. TIF procedure was also associated with a decrease in all acid exposure parameters while patients in the control group had no detectable improvements in pH control (p<0.001).

"In other studies, the therapeutic gain of PPI therapy over placebo for the control of regurgitation is modest. Data from this well designed study suggest that the TIF procedure provides an attractive option to manage troublesome GERD symptoms, especially considering a notable absence of troublesome dysphagia and bloating after the TIF procedure," said Dr Peter Kahrilas, Professor of Medicine-Gastroenterology, Northwestern University and co-principal investigator.

EndoGastric Solutions is currently awaiting the outcome of a CPT code meeting to enable payer reimbursement for its transoral GERD surgical device.

STAR Registry

The American Gastroenterological Association (AGA) Center for GI Innovation and Technology has previously created the STAR Registry, which is comparing laparoscopic surgery to an incisionless procedure to treat GERD. The Registry will provide the first real-world data observing patient outcomes following laparoscopic surgery and transoral fundoplication with the EsophyX device.

The STAR Registry is AGA’s first national observational registry. The AGA Center for GI Innovation and Technology does not endorse any product or service, develop guidelines, nor make any guarantees about FDA approval or coverage from public or private payors.

“Through the STAR Registry, the AGA will bring important data to the conversation about the benefits of surgery in patients with GERD, a condition that affects millions of people,” said Dr M Brian Fennerty, AGAF, professor of medicine at Oregon Health Sciences University and principal investigator for the STAR Registry. “This collaboration sets an important precedence for industry and professional societies to work together toward common goals. We will provide physicians, patients, purchasers and payors with additional long-term efficacy data about patients who choose surgical therapy for GERD, which is invaluable to patient care decisions.”

“GERD is a deceptively complex condition and the most commonly used treatment options may not adequately serve all patients. By collecting data on transoral incisionless vs. laparoscopic fundoplication in a well-designed observational registry, we are able to introduce FDA-cleared innovations to a larger audience, while continuing to evaluate safety, efficacy and comparative outcomes,” said Dr Emir Deljkich, Senior Director, Clinical and Medical Affairs and Medical Science Liaison.

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