Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study

Abstract

BackgroundThe aim of this randomized, crossover study was to determine if transoral fundoplication (TF) could further improve clinical outcomes in partial responders to high-dose (HD) proton-pump inhibitor (PPI) therapy and to evaluate durability of TF.MethodsIn seven United States centers, patients with hiatal hernia ≤2 cm and abnormal esophageal acid exposure (EAE) were randomized to TF (n = 40) or HD PPIs (n = 23) group. At 6-month follow-up, PPI patients underwent crossover. We assessed clinical outcomes 6-month post TF in crossover patients (COP), as compared to 6-month of HD PPI therapy, and 12-month outcomes in patients initially randomized to TF. The primary outcome was symptom control evaluated by Reflux Disease Questionnaire and Reflux Symptom Index. Secondary outcomes included healing of esophagitis, normalization of EAE and PPI use after TF. We analyzed 21 COP and 39 TF patients. McNemar’s test or Fisher exact test was used to compare proportions.ResultsOf 63 randomized patients, 3 were lost to follow-up, leaving 39 TF and 21 COP for analyses. In the COP, TF further improved control of regurgitation and of atypical symptoms achieved after six months of HD PPIs. Of 20 patients with GERD symptoms after six months of high-dose PPI therapy, 65% (13/20) reported global elimination of troublesome regurgitation and atypical symptoms post TF off PPIs; 67% (6/9) reported no troublesome regurgitation. Esophagitis further healed in 75% (6/8) of patients. Seventy-one percent of COP patients were off PPIs six months following TF. Normalization of EAE decreased from 52% after HD PPIs (on PPIs) to 33% after TF (off PPIs), p =0.388. In the original TF group, 12-month post TF, 77% of patients achieved complete symptom control, 82% ceased PPI therapy, 100% healed esophagitis and 45% normalized EAE.ConclusionsThe results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TF may provide further elimination of symptoms and esophagitis healing. In the original TF group, the clinical outcomes of TF remained stable between 6- and 12-month follow-up.Trail registrationClinicaltrials.gov: NCT01647958.Electronic supplementary materialThe online version of this article (doi:10.1186/1471-230X-14-174) contains supplementary material, which is available to authorized users.

Transoral fundoplication offers durable symptom control for chronic GERD: 3-year report from the TEMPO randomized trial with a crossover arm

“…In fact, PPI therapy may be less effective in controlling abnormal EAE in certain patients than previously thought [15]. The rate of pH normalization off PPIs noted in our study 3 years post-TF (40 %) is comparable to rates of pH normalization reported in patients on double-dose PPI therapy (approximately 50 %) [20, 23].…”

“…This is not the case in patients who receive the TF procedure, as de novo occurrence of post-procedure dysphagia and bloating is virtually nonexistent [14, 15, 24]. …”

“…The study design has been described previously [14, 15]. The trial was sponsored by the manufacturer of the EsophyX device which was used in performing the TF procedure.…”

Evolution and Outcome of Eight Patients Undergoing Treatment of Gastroesophageal Disease by Esophyx

“…This technique does not affect other future therapeutic options. Our results must be interpreted cautiously considering the limitations of this study, most notably the small sample of 8 patients only, the two centres, two gastroenterologists study; follow-up grossly observational; unique use of subjective measures of GERD severity by GERD-HRQL score (without follow up by endoscopy), relative short follow up duration (1 year) and restriction to sub-groups of GERD patients [18][19][20][21].…”

How can we deal with the GERD treatment gap?

“…TF may provide further control of acid reflux symptoms and heal esophagitis in patients who are refractory to high-dose PPI therapy. 16 A randomized, multicenter, open-label, crossover study evaluated whether TF could further improve clinical outcomes in partial PPI responders and the durability of such an effect. Patients with GERD and hiatal hernia ࣘ2 cm were randomized to the TF (n = 40) or high-dose PPI therapy (n = 23) groups.…”