Trial reportSurgical endoscopy2016
Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: long-term 3-year results.
Trial report in Surgical endoscopy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03476265 (Evaluation of Gastroesophageal Reflux Disease - Health Related Quality of Life After Lower Esophageal Sphincter), which is not on this map. Cited by 17 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Evaluation of Gastroesophageal Reflux Disease - Health Related Quality of Life After Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motilitygus (IEM)
Who cites it
17 citing papers in PubMed.
- Therapeutic Management of Gastroesophageal Reflux Disease (GERD)-Is There Something Between PPI and Fundoplication? An Overview.Journal of clinical medicine · 2025Review
- Review
- Endoscopic Advances in the Diagnosis and Management of Gastroesophageal Reflux Disease.Medicina (Kaunas, Lithuania) · 2024Review
- GERD after Bariatric Surgery: A Review of the Underlying Causes and Recommendations for Management.Current gastroenterology reports · 2024Review
- Prediction, prevention and management of gastroesophageal reflux after per-oral endoscopic myotomy: An update.World journal of gastroenterology · 2024Review
- Barrett's Esophagus and Intestinal Metaplasia.Frontiers in oncology · 2021Review
- Advanced Endoscopic Imaging and Interventions in GERD: An Update and Future Directions.Frontiers in medicine · 2021Review
- Electroceuticals in the Gastrointestinal Tract.Trends in pharmacological sciences · 2020Review
- Novel Therapies for Gastroesophageal Reflux Disease: Beyond Proton Pump Inhibitors.Current gastroenterology reports · 2020Review
- Tailored modern GERD therapy - steps towards the development of an aid to guide personalized anti-reflux surgery.Scientific reports · 2019Article
- Electrical lower esophageal sphincter augmentation in patients with GERD and severe ineffective esophageal motility-a safety and efficacy study.Surgical endoscopy · 2019Article
- Use of Bioelectronics in the Gastrointestinal Tract.Cold Spring Harbor perspectives in medicine · 2019Review
- Proposed approach to the challenging management of progressive gastroesophageal reflux disease.World journal of gastrointestinal endoscopy · 2018Review
- Novel Surgical Treatments for Gastroesophageal Reflux Disease: Systematic Review of Magnetic Sphincter Augmentation and Electric Stimulation Therapy.Gastroenterology research · 2018Review
- New Approaches to Gastroesophageal Reflux Disease.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2017Article
- [Surgical and interventional procedures for reflux therapy : Endoscopic or laparoscopic?]Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2017Review
- Electrical stimulation for gastroesophageal reflux disease: current state of the art.Clinical and experimental gastroenterology · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundElectrical stimulation of the lower esophageal sphincter (LES) has been shown to improve outcomes in patients with gastroesophageal reflux disease (GERD) at 2 years. The aim of the study was to evaluate the safety and efficacy of LES stimulation in the same cohort at 3 years.
methodsGERD patients with partial response to PPI, with % 24-h esophageal pH < 4.0 for >5 %, with hiatal hernia <3 cm and with esophagitis ≤LA grade C were treated with LES stimulation in an open-label 2-year trial. All patients were on fixed stimulation parameter of 20 Hz, 220 μs, 5 mA delivered in twelve, 30-min sessions. After completing the 2-year open-label study, they were offered enrollment into a multicenter registry trial and were evaluated using GERD-HRQL, symptom diaries and pH testing at their 3-year follow-up.
resultsFifteen patients completed their 3-year evaluation [mean (SD) age = 56.1 (9.7) years; men = 8] on LES stimulation. At 3 years, there was a significant improvement in their median (IQR) GERD-HRQL on electrical stimulation compared to both their on PPI [9 (6-10) vs. 1 (0-2), p = 0.001] and off PPI [22 (21-24) vs. 1 (0-2), p < 0.001]. Median 24-h distal esophageal acid exposure was significantly reduced from [10.3 (7.5-11.6) % at baseline vs. 3 (1.9-4.5) %, p < 0.001] at 3 years. Seventy-three % (11/15) patients had normalized their distal esophageal acid exposure at 3 years. Remaining four patients had improved their distal esophageal acid exposure by 39-48 % from baseline. All but four patients reported cessation of regular PPI use (>50 % of days with PPI use); three had normal esophageal pH at 3 years. There were no unanticipated device- or stimulation-related adverse events or untoward sensation reported during the 2- to 3-year follow-up.
conclusionLES-EST is safe and effective for treating patients with GERD over long-term, 3-year duration. There was a significant and sustained improvement in esophageal acid exposure and reduction in GERD symptoms and PPI use. Further, no new GI side effects or adverse events were reported.
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Registered trials
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