Long-Term Outcome of Endoluminal Gastroplication (ELGP) for the Treatment of Gastroesophageal Reflux Disease (GERD): The First Multicenter Trial in Japan

Abstract

Background: Endoluminal gastroplication (ELGP) is a method of endoscopic therapy for patients with gastroesophageal reflux disease (GERD). Long-term outcome should be investigated because the duration of the efficacy of ELGP is an important point for judging the usefulness of ELGP. Aim: To evaluate the long-term effectiveness of ELGP in a multicenter trial in Japan. Methods: The inclusion criteria were a QUEST symptom score of 4 or more and endoscopic Los Angeles grade A, B, or C esophagitis. The exclusion criteria were age under 18 years, pregnancy, obesity (BMI>40), previous esophageal surgery, and a hiatal hernia greater than 2 cm in length. In all patients the procedure consisted of placing circumferential plications 1 to 2 cm below the GE junction with the EndoCinch system (Bard Inc., USA). Endoscopy and symptom assessments were performed before ELGP, and they were repeated 3, 6, 12, 18, and 24 months after ELGP to monitor clinical outcome. pH measurements were performed before ELGP and 3 months after ELGP. The HB frequency score (HBFS) defined as follows: 1 = none, 2 = < 3 episodes per week, 3 = 3-5 episodes per week, 4 = 6-7 episodes per week. The HB severity score (HBSS) was recorded by the patients themselves by using a 5-point visual analog scale (1-5). Results: Forty-eight patients were enrolled (31 men, 17 women; mean age: 58 years). The mean QUEST symptom score was 9.0. The total number of plications created per procedure was 2.4, and the average procedure time was 75.6 minutes. There were significant reductions in both the HBFS and HBSS: the HBFS decreased from an average of 3.8 at baseline to 1.8, 1.8, 1.6, 1.6, and 1.5 at 3, 6, 12, 18, and 24 months, respectively, after ELGP (P < 0.001), while the HBSS decreased from an average of 3.9 to 1.8, 1.9, 1.3, 1.4, and 1.5 at 3, 6, 12, 18, and 24 months, respectively, after ELGP (P < 0.001). The endoscopic grade had improved in 81% of the patients at 3 months after ELGP. The percentage time spent with a pH below 4 in 27 patients decreased from 23% pre-ELGP to 10% post-ELGP (P = 0.01). Neither major adverse events nor deaths occurred. The rates of PPI or H2RA- off or decrease were 69%, 67%, 69%, 69%, and 75% at 3, 6, 12, 18, and 24 months, respectively, after ELGP. The survival rate of more than one plications was 75%, 68%, 59%, 59%, and 59% at 3, 6, 12, 18, 24 months after ELGP, respectively. Conclusion: ELGP is effective for up to 24 months in about 70% of patients. This long duration of effectiveness may be because residual plications and/or scar formation as a result of the initial plications prevent gastroesophageal reflux to some extent.