Endoscopic gastroplication for the treatment of gastro-oesophageal reflux disease: a randomised, sham-controlled trial

Abstract

Background: Endoscopic treatment for gastro-oesophageal reflux disease (GORD) is rapidly emerging, but there is a great need for randomised controlled trials to evaluate the efficacy. Design and setting: A single-centre, double-blind, randomised, sham-controlled trial of endoscopic gastroplication by the Endocinch suturing system. Patients and interventions: 60 patients with GORD were randomly assigned to three endoscopic gastroplications (n = 20), a sham procedure (n = 20) or observation (n = 20). The research nurse and patients in the active and sham groups were blinded to the procedure assignment. After 3 months, open-label active treatment was offered to all patients. Outcome measures: The primary outcome measures were proton pump inhibitor (PPI) use and GORD symptoms, and secondary measures were quality of life, 24-h oesophageal acid exposure, oesophageal manometry and adverse events. Follow-up assessments were performed at 3, 6 and 12 months. Results: At 3 months, the percentage of patients who had reduced drug use by >50% was greater in the active treatment group (65%) than in the sham (25%) or observation groups (0%) (p,0.02). Symptoms (heartburn and to a lesser extent regurgitation) improved more in the active group than in the sham group. Three Short Form-20 quality of life subscales (role function, general health and bodily pain perception) improved in the active group versus sham. Oesophageal acid exposure was modestly decreased after active treatment (p,0.02), but not significantly greater than after the sham procedure (p = 0.61). The active treatment effects on PPI use, symptoms and quality of life persisted after 6 and 12 months of open-label follow-up (n = 41), but 29% of patients were retreated in this period. No serious adverse events occurred. Conclusions: Endoscopic gastroplication, using the Endocinch device, reduced acid-inhibitory drug use, improved GORD symptoms and improved the quality of life at 3 months compared with a sham procedure. The effects persisted up to 12 months. However, the reduction in oesophageal acid exposure was not greater after endoscopic treatment than after a sham procedure.

EndoCinch® Treatment for Gastro-Oesophageal Reflux Disease

“…After 1 year, a sustained significant improvement in symptom scoring, regurgitation, and quality of life and a reduction in the requirement of PPIs have been reported [43]. Schwartz et al [48] recently reported the first EndoCinch sham-controlled trial. The results of this trial confirm those of prior open-label studies [43, 44, 49], showing that in the short and intermediate terms, endoscopic gastroplication improves GORD symptoms and quality of life and reduces the requirements of acid-inhibitory drugs.…”

“…In the sham-controlled study reported by Schwartz et al [48], endoscopy/gastroplication was performed only in patients of the active treatment group who had treatment failure, and hence the actual proportion of patients who have retention of stitches (or judged to be functional) is unknown in this group. However, retention of stitches seems to be a major problem reported with this technique [48, 52, 53]. Further studies are needed to confirm the above.…”

Electrical Stimulation Therapy for Gastroesophageal Reflux Disease

“…Less-invasive endoscopic suturing devices as the Endocinch (Bard Endoscopic Technologies, Nurray Hill, NJ, USA), Plicator (NDO Surgical Inc., Mansfield, MA, USA) and the EsophyX (EndoGastric Solutions, Inc., Silver Spring, MD, USA) have tried to mimic the effects of conventional anti-reflux surgery by the creation of gastroesophageal plications. [29][30][31] Although early improvements in symptoms and medication use were reported in several trials, clinical efficacy or durability to the level of conventional anti-reflux surgery have not been met. 32 The Enteryx procedure aimed to increase sphincter competence by injection of sponge-like material into the LES.…”

“…Currently, 18 patients have completed 3-month follow-up and 14 patients 6-month follow-up. Interim results showed a positive ef- fect on symptoms: GERD-HRQL median (IQR) score was 4 (2-11) at 3 months and 5 (4-9) at 6 months, respectively with P < 0.001 and P < 0.01 when compared to baseline score off PPI (31 [25][26][27][28][29][30][31][32][33][34][35][36][37]). Furthermore, acid exposure time decreased from 11.3% (9.0-15.5%) at baseline to 3.3% (2.5-9.1%) at 3 months and to 2.6% (1.8-5.4%) at 6 months (Fig.…”

Transoral surgery for morbid obesity

“…Bard, Murray Hill, NJ), was first described in the context of treating gastroesophageal reflux disease. Due to lack of repair durability, the role of EVG in control of gastroesophageal reflux disease (GERD) was abandoned [25][26][27] . In terms of its application for the treatment of obesity, Fogel et al [28] first described the use of the EndoCinch in 64 patients.…”