摘要
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.
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.
