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Latest data highlights benefits of TIF procedure
EndoGastric Solutions has announced that Dr Karim Trad presented a review of data from EndoGastric Solutions’ multi-centre, randomised, controlled TEMPO and RESPECT studies for the Transoral Incisionless Fundoplication (TIF) procedure at SAGES 2015, the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (15-18 April) in Nashville, TN.
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.
RESPECT is the first-ever blinded, randomised, sham- and placebo-controlled, multicenter clinical study of the TIF procedure. As previously reported, 67% of the 87 patients who were randomly assigned to the group that underwent the TIF procedure and then received an ongoing course of placebo medication reported elimination of troublesome regurgitation per Montreal consensus criteria after six months. Meanwhile, of the 42 patients who were randomised to undergo sham surgery and then continued an optimized dose of proton pump inhibitor (PPI) regimen (omeprazole), 45% reported elimination of the same symptom (p=0.023).
In addition, 77% of the TIF patients had healed their reflux esophagitis. The 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).
TEMPO is a prospective, randomised, multi-centre clinical trial during which all 21 patients in the original control arm who had received maximum-dose proton pump inhibitor (PPI) therapy for the first six months of the trial crossed over to undergo the TIF procedure. This group achieved similar positive six-month results to the patients in the original treatment arm. Seventy-seven percent of patients in original treatment arm (n=39) reported a global elimination of daily troublesome regurgitation and atypical symptoms 12 months following the TIF procedure. Oesophagitis, remained healed in 100% of the patients in the original treatment arm.
“Taken together, these two well-designed, controlled trials highlight the significant benefits of the TIF procedure in well-selected GERD patients with incomplete symptom control on high-dose PPI therapy,” said Trad, surgeon at George Washington University School of Medicine and Health Sciences and the principal investigator of the TEMPO study who also participated in the RESPECT study. “The TIF procedure is capable of dramatically eliminating GERD symptoms, healing esophagitis and improving quality of life with minimal or no side effects. The recent multi-center study data has proven this incisionless, endoluminal approach as more effective than PPI drugs at eliminating troublesome regurgitation in a sub-group of chronic GERD patients, which is a significant achievement for this disease,” explained Trad.