Brief Article
Copyright ©2013 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastrointest Pharmacol Ther. Nov 6, 2013; 4(4): 120-126
Published online Nov 6, 2013. doi: 10.4292/wjgpt.v4.i4.120
Four-year follow-up of endoscopic gastroplication for the treatment of gastroesophageal reflux disease
Matthijs P Schwartz, J Rieneke C Schreinemakers, André J P M Smout
Matthijs P Schwartz, Department of Gastroenterology, Meander Medical Center, 3800 BM Amersfoort, The Netherlands
J Rieneke C Schreinemakers, André J P M Smout, Department of Gastroenterology, University Medical Center, 3508 GA Utrecht, The Netherlands
Author contributions: Schwartz MP, Smout AJPM designed research; Schwartz MP performed research; Schwartz MP, Schreinemakers JRC analyzed data and wrote the paper; Schwartz MP, Smout AJPM revised the paper for final approval.
Correspondence to: Matthijs P Schwartz, MD, PhD, Department of Gastroenterology, Meander Medical Center, PO Box 1502, 3800 BM Amersfoort, The Netherlands. mp.schwartz@meandermc.nl
Telephone: +31-33-8501162 Fax: +31-33-8502631
Received: August 13, 2013
Revised: October 9, 2013
Accepted: October 15, 2013
Published online: November 6, 2013
Processing time: 83 Days and 7.1 Hours
Abstract

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.

Keywords: Endoscopic therapy; Endocinch; Gastroesophageal Reflux; Gastroplication; Follow-up studies

Core tip: The long-term efficacy of the first commercially available endoluminal suturing device for the treatment of gastroesophageal reflux disease (GERD), Endocinch, was evaluated. In the 4-year follow-up period, the subset of GERD patients that benefit from endoscopic gastroplication kept declining gradually. Up to 80% of patients again required acid-suppressive medication, making this endoscopic treatment procedure unsuccessful for the majority of GERD patients.