Subjective and objective data on esophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness plication for the treatment of GERD by using multiple plication implants

Background Subjective and especially objective data after endoluminal full-thickness gastroplication are scarce. Objective To evaluate symptoms and reflux activity 12 months after gastroplication by using multichannel intraluminal impedance monitoring. Design Open-label, prospective, single-center study. Setting Tertiary referral hospital in Zell am See, Austria. Patients Subjects without hiatal hernias with documented GERD and persistent or recurrent symptoms despite treatment with a proton pump inhibitor. Interventions A total of 36 patients underwent endoscopic full-thickness gastroplication with 1 or more Plicator implants. Main Outcome Measurements Mean Gastrointestinal Quality of Life Index and reflux-specific symptom scores significantly improved on follow-up ( P < .01). Atypical reflux, gas/bloating, and bowel dysfunction–specific symptom scores as well as belching and dysphagia scores improved. Twenty-two patients returned for esophageal manometry and multichannel intraluminal impedance testing 1 year after surgery. DeMeester scores decreased from 20 to 10 ( P < .029). The median numbers of total, acid, proximal, upright, and recumbent reflux episodes were all significantly reduced ( P < .05). Manometric data were virtually unchanged. The percentage of patients taking proton pump inhibitors on daily basis after the procedure was 11.5%. There was only 1 postprocedure incident (bleeding) that required intervention. Three of 36 patients (8.3%) were considered treatment failures because of persistent symptoms and were assigned to undergo laparoscopic fundoplication. Limitations No randomized comparison with a sham procedure or laparoscopic fundoplication; follow-up interval. Conclusions Endoscopic plication is safe and improves objective and subjective parameters at 1-year follow-up, without side effects seen after laparoscopic fundoplication. Further studies on the clinical merit of this procedure in specific patient populations are warranted. ( Clinical Trial registration number : NCT01453985 .)