Transoral Incisionless Fundoplication for Treatment of Pediatric Gerd: 12-Month Results of a Feasibility Study

Mike Thomson, MD, A Lobontiu, MD, R Stewart, MD, P Rao, MD, S Marven. Centre for Paediatric Gastroenterology, Sheffield Children’s NHS Trust, Sheffield, U.K.

OBJECTIVE: Transoral incisionless fundoplication (TIF) using EsophyX was evaluated for the treatment of pediatric gastroesophageal reflux disease using subjective and objective outcomes.
METHODS AND PROCEDURES: Inclusion criteria were chronic and symptomatic GERD, refractory to or dependent on high dose proton pump inhibitor (PPI) therapy. Exclusion criteria were >18 years of age, dysphagia, obesity, previous upper intestinal surgery, or hiatus hernia > 2 cm. Pre-procedure assessment consisted of upper GI endoscopy, 24-h esophageal pH, and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire. The TIF procedure reconstructed the antireflux barrier through augmentation of the GE junction tightness. The TIF procedure was performed using EsophyX following a standardized TIF2 protocol.
RESULTS: Ten patients [8 male, median age 12 (range 9-16) years, weight 43.7 (28.0-91.0) kg] underwent TIF because they suffered from GERD for 45 (24-70) months, had documented gastroesophagael reflux by abnormal pH-metry (pH<4 for >6% of time) or esophagitis, and were on antisecretory medication. Hiatus hernia was present in two patients and was reduced during TIF. Median operative time was 42 (25-94) min. In all patients a wrap of 270 degrees and 1-3 cm in length was achieved. The first two patients experienced pneumomediastinum shown on CT scan, but no leak was revealed on barium swallow. One of these two patients was treated for possible mediastinitis and discharged after 5 days of intravenous antibiotics. CO2 insufflation was employed on subsequent patients and resulted in no further complications. At each 6-month and 12-month follow-up, reflux index and QOLRAD scores were significantly reduced, and 80% of patients discontinued PPIs completely.

CONCLUSION: The TIF procedure using EsophyX was feasible and safe in children. Subjective and objective outcomes at one year were significantly improved, and PPIs were discontinued by 80% of patients.