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AIM:To evaluate the efficacy,safety,and long-term outcomes of endoluminal gastroplication(ELGP) in patients with proton pump inhibitor(PPI)-resistant,nonerosive reflux disease(NERD).METHODS:The subjects were NERD patients,diagnosed 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 PPI medication,patients’ symptoms and quality of life(QOL) were assessed using the questionnaire for the diagnosis of reflux disease,the frequency scale for symptoms of gastro-esophageal reflux disease(FSSG),gastrointestinal symptoms rating scale,a 36-item short-form.In addition,24-h esophageal pH monitoring or 24-h intraesophageal pH/impedance(MII-pH) monitoring was performed.The Bard EndoCinch TM was used for ELGP,and 2 or 3 plications were made.After ELGP,all acid reducers were temporarily discontinued,and medication 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 evaluated 12 mo after ELGP to investigate long-term effects.RESULTS:The mean FSSG score decreased significantly from before ELGP to 3 and 12 mo after ELGP(19.1 ± 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 ± 0.8 and 0.8 ± 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 mo,and 2.0 and 2.8,respectively,after 12 mo,showing no correlation to plication loss.On pH monitoring,there was no difference 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 ± 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 altogether.After 12 mo,3 patients(16.7%) were able to reduce the amount of PPI medication by 50% or more,and 12 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.
AIM: To evaluate the efficacy, safety, and long-term outcomes of endoluminal gastroplication (ELGP) in patients with proton pump inhibitor (PPI) -resistant, nonerosive reflux disease (NERD). METHODS: The subjects were NERD patients, diagnosed 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 PPI medication, patients’ symptoms and quality of life (QOL) were assessed using the questionnaire for the diagnosis of reflux disease, the frequency scale for symptoms of gastro-esophageal reflux disease (FSSG), gastrointestinal symptoms rating scale, a 36-item short- form. Addition, 24-h esophageal pH monitoring or 24-h intraesophageal pH / impedance (MII-pH) monitoring was performed. The Bard EndoCinch ™ was used for ELGP, and 2 or 3 plications were made. After ELGP, all acid reducers were temporarily discontinued, and the medication was resumed depending on the development an d severity of symptoms.Three mo after ELGP, symptoms, QOL, pH or MII-pH monitoring, number of applications, and PPI services were evaluated. Library, symptoms, number of applications, and PPIs were 12 weeks after ELGP to investigate long-term effects .RESULTS: The mean FSSG score decreased significantly from before ELGP to 3 and 12 months after ELGP (19.1 ± 10.5 to 10.3 ± 7.4 and 9.3 ± 9.9, P <0.05, respectively). at 3 and 12 months after ELGP (2.4 ± 0.8 to 1.2 ± 0.8 and 0.8 ± 1.0, P <0.05, respectively). FSSG scores in cases with no remaining plications and in cases with one or more remaining applications were 4.4 and 2.7, respectively, after 3 mo, and 2.0 and 2.8, respectively, after 12 mo, showing no correlation to plication loss. On pH monitoring, there was no difference 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 fr om before ELGP to 3 mo after, but the symptom sensitivity index decreased significantly 3 months after ELGP (16.1 ± 12.9 to 3.9 ± 8.3, P <0.01). At 3 months after ELGP, 6 patients (31.6% 50% or more, and 11 patients (57.9%) were able to discontinue PPI treatment altogether. After 12 months, 3 patients (16.7%) were able to reduce the amount of PPI medication by 50% or more, and 12 patients (66.7 %) were able to discontinue PPI medication altogether. A high percentage of cases with remaining plications had discontinued PPIs after 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 than long used in patients with PPI-refractory NERD.