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 and 4 out of 6 QoL subscales were improved (all P < 0.01 compared 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.
RCT Entities:
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 and 4 out of 6 QoL subscales were improved (all P < 0.01 compared 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.
Authors: H Abou-Rebyeh; N Hoepffner; T Rösch; E Osmanoglou; J H Haneke; R E Hintze; B Wiedenmann; H Mönnikes Journal: Endoscopy Date: 2005-03 Impact factor: 10.093
Authors: J E Bais; J F Bartelsman; H J Bonjer; M A Cuesta; P M Go; E C Klinkenberg-Knol; J J van Lanschot; J H Nadorp; A J Smout; Y van der Graaf; H G Gooszen Journal: Lancet Date: 2000-01-15 Impact factor: 79.321
Authors: Yang K Chen; Isaac Raijman; Tamir Ben-Menachem; Anthony A Starpoli; Julia Liu; Haleh Pazwash; Stacey Weiland; Mamun Shahrier; Evelina Fortajada; John R Saltzman; David L Carr-Locke Journal: Gastrointest Endosc Date: 2005-05 Impact factor: 9.427
Authors: Hubertus Feussner; Valentin Becker; Margit Bauer; Michael Kranzfelder; Rebekka Schirren; Tim Lüth; Alexander Meining; Dirk Wilhelm Journal: Clin Exp Gastroenterol Date: 2014-12-18