Objective: To determine the safety, mechanism of action, immediate postprocedural anatomic impact on the esophagogastric junction, and short-term efficacy of the first entirely endolumenal antireflux procedure.
Background: A safe and effective endoscopic antireflux procedure remains elusive. Transoral endolumenal surgery has enormous potential for the treatment of gastroesophageal reflux disease (GERD) and other esophagogastric diseases. A canine model was used to study a novel endoscopic device, which allows for creation of an endoluminal fundoplication.
Methods: The transoral incisionless fundoplication (TIF) was performed in 21 canines in a phase I feasibility and safety study, and in 21 canines in a phase II study that included a detailed objective assessment of the effects of 2 variants of the TIF procedure (TIF 1.0 and TIF 2.0) versus sham on esophageal physiology and esophagogastric junction (EGJ) anatomy.
Results: In phase I, TIF provided a safe and feasible endolumenal therapy for GERD, with histologic data that demonstrated serosal fusion of approximated full-thickness tissue plications and durability of the fundoplication. TIF procedures effectively reduced cardia circumference and improved Hill classification grade. In phase II, the TIF 2.0 procedure achieved normalization of distal esophageal acid exposure and increased lower esophageal sphincter (LES) pressure and length based on objective testing over a 2-week period. TIF 2.0 demonstrated superior results to TIF 1.0, and valve appearance and location exhibited similarity to the Nissen fundoplication by vector volume analysis.
Conclusions: The TIF procedure is safe and results in a durable and functional fundoplication as well as a platform for further development and modification of the procedure, which can be use to impact outcome. This work provides the foundation for human translation and assessment of long-term outcomes.
This first objective assessment of the endolumenal approach to fundoplication in a canine model demonstrated procedural safety, long-term serosal apposition, and esophagogastric junction reconstruction similar to the Nissen fundoplication. Short-term follow-up demonstrated normalization of esophageal acid exposure.
From the *Division of Thoracic and Foregut Surgery, Heart, Lung and Esophageal Surgery Institute, University of Pittsburgh, Pittsburgh, Pennsylvania; †Department of Surgery, Oregon Health and Science University, Portland, Oregon; ‡Department of Medical Physics and Clinical Bioengineering, Trinity College, Dublin, Ireland; §Center for Visceral Biomechanics and Pain, Aalborg Hospital, Hobrovej, Denmark; ¶Department of Anatomic Pathology, Section of Morphologic and Molecular Pathology, Cleveland Clinic, Cleveland, Ohio; **EndoGastric Solutions, Inc., Redmond, Washington.
Supported in part by National Institutes of Health grant K23 DK066165-01 (BAJ), American Surgical Association Career Development Award (RWO), and EndoGastric Solutions, Inc. (BAJ).
Reprints: Blair A. Jobe, MD, Division of Thoracic and Foregut Surgery, Heart, Lung and Esophageal Surgery Institute, University of Pittsburgh, Pittsburgh, PA 15232. E-mail: email@example.com.