Efficacy of endoluminal gastroplication in Japanese patients with proton pump inhibitor-resistant,non-erosive esophagitis

AIM： To evaluate the efficacy, safety, and long-term outcomes of endoluminal gastroplication （ELGP） in pa- tients with proton pump inhibitor （PPI）-resistant, non- erosive reflux disease （NERD）. METHODS： The subjects were NERD patients, diag- nosed by upper endoscopy before PPI use, who had symptoms such as heartburn or reflux sensations two or more times a week even after 8 wk of full-dose PPI treatment. Prior to ELGP, while continuing full-dose PPImedication, patients＇ symptoms and quality of life （QOL） were assessed using the questionnaire for the diagno- sis of reflux disease, the frequency scale for symptoms of gastro-esophageal reflux disease （FSSG）, gastroin- testinal symptoms rating scale, a 36-item short-form. In addition, 24-h esophageal pH monitoring or 24-h in- traesophageal pH/impedance （MII-pH） monitoring was performed. The Bard EndoCinchTM was used for ELGP, and 2 or 3 plications were made. After ELGP, all acid reducers were temporarily discontinued, and medica- tion was resumed depending on the development and severity of symptoms. Three mo after ELGP, symptoms, QOL, pH or MII-pH monitoring, number of plications, and PPI medication were evaluated. Further, symptoms, number of plications, and PPI medication were evalu- ated 12 mo after ELGP to investigate long-term effects. RESULTS： The mean FSSG score decreased signifi- cantly from before ELGP to 3 and 12 mo after ELGP （19.1 ：k 10.5 to 10.3 ＋ 7.4 and 9.3 ＋ 9.9, P 〈 0.05, respectively）. The total number of plications decreased gradually at 3 and 12 mo after ELGP （2.4 ＋ 0.8 to 1.2 ：l： 0.8 and 0.8 ：l： 1.0, P 〈 0.05, respectively）. The FSSG scores in cases with no remaining plications and in cases with one or more remaining plications were 4.4 and 2.7, respectively, after 3 too, and 2.0 and 2.8, respectively, after 12 mo, showing no correlation to plication loss. On pH monitoring, there was no differ- ence in the percent time pH 〈 4 from before ELGP to 3 mo after. Impedance monitoring revealed no changes in the number of reflux episodes or the symptom index for reflux events from before ELGP to 3 mo after, but the symptom sensitivity index decreased significantly 3 mo after ELGP （16.1：1：12.9 to 3.9 ~ 8.3, P 〈 0.01）. At 3 mo after ELGP, 6 patients （31.6%） had reduced their PPI medication by 50% or more, and 11 patients （57.9%） were able to discontinue PPI medication alto- gether. After 12 mo, 3 patients （16.7%） were able toreduce the amount of PPI medication by 50% or more, and 22 patients （66.7%） were able to discontinue PPI medication altogether. A high percentage of cases with remaining plications had discontinued PPIs medication after 3 mo, but there was no difference after 12 mo. No serious complications were observed in this study. CONCLUSION： ELGP was safe, resulted in significant improvement in subjective symptoms, and allowed less medication to be used over the long term in patients with PPI-refractory NERD.

Four-year follow-up of endoscopic gastroplication for the treatment of gastroesophageal reflux disease

AIM:To evaluate the long-term effect of Endocinch treatment for gastroesophageal reflux disease(GERD).METHODS:After unblinding and crossover,50 patients(32 males,18 females; mean age 46 years) with pH-proven chronic GERD were recruited from an initial randomized,placebo-controlled,single-center study,and included in the present prospective open-label follow-up study.Initially,three gastroplications using the Endocinch device were placed under deep sedation in a standardized manner.Optional retreatment was offered in the first year with 1 or 2 extra gastroplications.At baseline,3 mo after(re) treatment and yearly proton pump inhibitor(PPI) use,GERD symptoms,quality of life(QoL) scores,adverse events and treatment failures(defined as:patients using > 50% of their baseline PPI dose or receiving alternative antireflux therapy) were assessed.Intention-to-treat analysis was performed.RESULTS:Median follow-up was 48 mo [interquartile range(IQR):38-52].Three patients were lost to follow-up.In 44% of patients retreatment was done after a median of 4 mo(IQR:3-8).No serious adverse events occurred.At the end of follow-up,symptom scores and4 out of 6 QoL subscales were improved(all P < 0.01compared to baseline).However,80% of patients required PPIs for their GERD symptoms.Ultimately,64% of patients were classified as treatment failures.In 60% a post-procedural endoscopy was carried out,of which in 16% reflux esophagitis was diagnosed.CONCLUSION:In the 4-year follow-up period,the subset of GERD patients that benefit from endoscopic gastroplication kept declining gradually,nearly half opted for retreatment and 80% required PPIs eventually.