Background and study aims The rate of gastroesophageal reflux disease (GERD) after per oral endoscopic myotomy (POEM) is concerning. Endoscopic anti-reflux methods, such as Trans Oral Incisionless Fundoplication (TIF), are crucial for the long-term success of POEM, especially if they can be performed in the same session. Methods We completed a proof-of-concept canine pilot study (n = 6) to assess safety and feasibility of POEM and TIF in a single session (POEM-TIF). Subsequently, POEM-TIF was also performed in patients with achalasia (n = 5). Herein, we report on the safety, technical and clinical success of the first-in-human cases with symptom follow-up at 1, 3 and 6 months and pH testing at 6 months. Results POEM was completed successfully in six canines (3 anterior and 3 posterior myotomies), followed by TIF in the same session. Necropsy and extensive testing demonstrated no evidence of mucosal injury and no leaks. The reconstructed valve was 220 to 240 degrees, 3 to 4 cm in length, and resulted in concomitant esophageal lengthening (2-5 cm). Using similar principles, the first-in-human cases were performed without intraprocedural or delayed adverse events. pH testing at 6 months showed that four of five patients had no evidence of GERD (DeMeester > 14.72), and in one case, there was evidence of esophagitis. Conclusions Single session POEM-TIF appears to be safe and feasible. Early clinical human data suggests that it may be able to reduce post POEM GERD, however the additional secondary benefits such as lengthening and straightening of the esophagus, may prove to be equally important for the long-term success of POEM.
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