Evaluation of a novel endoluminal stapling procedure to restrict the lower esophageal sphincter and reduce reflux

Background and study aims: An effective, safe, and long-lasting endoluminal treatment for gastroesophageal reflux disease (GERD) would be an attractive prospect. We developed an endoluminal technique to restrict and tighten the lower esophageal sphincter (LES), by using a transoral endoscopic stapling device in a porcine model.

Patients and methods: Pre-interventional evaluation comprised endoscopy, manometry, and 48-hour pH measurement of the distal esophagus using the catheterless BRAVO pH capsule. By placing the endoluminal stapling device at the LES and firing a 2.5-cm staple line, a vertical plication was created. In five pilot pigs (phase 1), plications were placed in various locations at the LES. In another five pigs (phase 2), plications were placed uniformly at the mid level of the LES on the lesser curvature side. Measurements were repeated 2 weeks after the procedure. Necropsy and histological analysis were performed.

Results: Endoluminal stapling was successfully completed in all animals. In phase 2, the median procedure time was 15 minutes (range 10 – 55 minutes). LES pressure increased from 10.5 mmHg (± 2.5mmHg) to 14.3 mmHg (± 3.8 mmHg) (P = 0.038). Median percentage of time with pH below 4 decreased from 6.6 % (range 2.9 % – 48.8 %) to 2.2 % (range 0 % – 10.4 %) (P = 0.043). Histology showed the staple line involving the muscular layer in all pigs. A gap was present in the central part of the staple line in three pigs resulting in a mucosa-muscular bridge of tissue. This bridge did not influence the results.

Conclusion: This novel endoluminal technique is feasible and safe in a porcine model over 2 weeks. It is appealing due to its simplicity and ease of application. Further studies aimed at eliminating the gap in the staple line and investigating more animals over longer survival periods are needed.

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