ABSTRACT
BACKGROUND: The functional lumen imaging probe (FLIP) uses impedance planimetry to measure the geometry of a distensible organ. The purpose of this study was to evaluate FLIP as a method to determine structural changes at the gastroesophageal junction (GEJ) following transoral incisionless fundoplication (TIF) and compare these findings with the accepted methods of esophageal testing. METHODS: Two different approaches (TIF1.0 and 2.0) using the EsophyX™ device were performed in six and five animals, respectively. Three dogs underwent a sham procedure. FLIP measurements were performed pre- and post-procedure and at 2-week follow-up. Upper endoscopy, manometry, and 48-h pH testing were also performed at each time point. FLIP was performed in ten patients before and 3 months after TIF. RESULTS: Following TIF procedures, there was a significant decrease in cross-sectional area (CSA) of GEJ compared to baseline; however, the CSA of both groups returned to baseline at 2-week follow-up. The FLIP results were supported with pH testing and correlated highly with both measures of GEJ structural integrity (LES and cardia circumference). Following TIF in humans, there was a decrease in GEJ distensibility compared to baseline that persisted to the 3-month evaluation. CONCLUSION: FLIP is able to measure and display changes in tissue distensibility at the GEJ, and results correlate with established methods of testing. FLIP may represent a single testing modality by which to diagnose GERD and evaluate the outcome after antireflux surgery.
Subject(s)
Diagnostic Imaging/methods , Endoscopy, Gastrointestinal/methods , Esophagogastric Junction/pathology , Fundoplication/methods , Gastroesophageal Reflux/diagnosis , Adult , Animals , Disease Progression , Dogs , Elasticity , Esophageal pH Monitoring , Esophagogastric Junction/physiopathology , Esophagogastric Junction/surgery , Female , Follow-Up Studies , Gastroesophageal Reflux/physiopathology , Gastroesophageal Reflux/surgery , Humans , Male , Manometry , Middle Aged , Postoperative Period , Pressure , Treatment OutcomeABSTRACT
BACKGROUND: Long-term (> 5 years) studies of antireflux operations are needed. This study evaluates long-term results of the open Hill repair at multiple institutions. METHODS: This is a retrospective cohort study of open Hill repairs from 1972 to 1997 at 5 North American medical centers with a mean follow-up of 10 years. Objective data and standardized clinical outcomes were collected at a central site. Subjective results, medication use, and satisfaction scales were obtained through scripted phone interview. Results between 2 Hill-trained centers and 3 independent centers were compared. RESULTS: One thousand one hundred eighty-one patients met the inclusion criteria. Symptomatic improvement was found in 97% and good to excellent results in 93%. Medication use was markedly reduced. Hiatal hernia recurrence was found in 77 (6.9%); the reoperation rate was 1.9%. Differences in outcomes between Hill centers and independent centers were minor. CONCLUSIONS: Excellent results with the open Hill repair are durable beyond 10 years and are reproducible. Anatomic recurrence and reoperative rates are low.
Subject(s)
Esophagus/surgery , Fundoplication/methods , Gastroesophageal Reflux/surgery , Female , Follow-Up Studies , Humans , Male , Middle Aged , Patient Satisfaction , Retrospective Studies , Suture Techniques , Time Factors , Treatment OutcomeABSTRACT
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.
