Trial reportGut2022
Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial.
Trial report in Gut, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03322553 (Endoscopic Full Thickness Plication), which is not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Endoscopic Full Thickness Plication (GERD-X) for the Treatment of PPI Dependent GERD: Randomized, Double Blinded, Sham Controlled Trial
Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it, 57 citations in OpenAlex.
- Pooled it
- Efficacy and safety of anti-reflux mucosal ablation therapy at 12 months.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2025Trial
- Trial
- Efficacy and Safety of Closure-Focused Anti-Reflux Mucoplasty Compared With Conventional ARMS: A Propensity Score-Matched Study (With Video).Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2026Article
- A pilot study on anti-reflux mucoplasty with valve as novel endoscopic therapy for gastroesophageal reflux disease.DEN open · 2026Article
- Targeted Endoscopic Therapies for Gastro-Esophageal Reflux Disease (GERD): A Narrative Review.Journal of personalized medicine · 2026Review
- Transient Gastric Pressure Elevation Synergizing With Impaired Esophagogastric Junction Barrier Function Plays a Pivotal Role in the Refractory Gastroesophageal Reflux Disease.Journal of neurogastroenterology and motility · 2026Article
- Peroral Endoscopic Cardial Constriction with Band Ligation for Gastroesophageal Reflux Disease: A Prospective Pilot Study.Endoscopy international open · 2026Article
- Efficacy of endoscopic radiofrequency ablation for proton pump inhibitor-dependent gastroesophageal reflux disease: Multicenter prospective cohort study.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2025Article
- Article
- American Society for Gastrointestinal Endoscopy guideline on the diagnosis and management of GERD: methodology and review of evidence.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2025Article
- Therapeutic Management of Gastroesophageal Reflux Disease (GERD)-Is There Something Between PPI and Fundoplication? An Overview.Journal of clinical medicine · 2025Review
- Unveiling the intricacies: Insight into gastroesophageal reflux disease.World journal of gastroenterology · 2025Review
- Development and Application of Endoscopic Antireflux Mucosectomy in Treating Refractory Gastroesophageal Reflux Disease.Gastroenterology research and practice · 2025Review
- Article
- The Saudi Gastroenterology Association consensus on the clinical care pathway for the diagnosis and treatment of GERD.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2024Article
- Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Systematic Review and Meta-Analysis of Randomized Sham Controlled Trials.JGH open : an open access journal of gastroenterology and hepatology · 2024Article
- Improving treatment of people with gastro-esophageal reflux disease refractory to proton pump inhibitors.Communications medicine · 2024Review
- Anti-Reflux Mucosal Ablation: One More Kid in Town for the Treatment of Gastroesophageal Reflux Disease.GE Portuguese journal of gastroenterology · 2024Article
- Endoscopic Advances in the Diagnosis and Management of Gastroesophageal Reflux Disease.Medicina (Kaunas, Lithuania) · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD.
designPatients with proton pump inhibitor (PPI)-dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months.
resultsSeventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29-42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9-100.0) versus 8.0 (2.2-21.6); p<0.001) and 12 (92.3 (84.4-100.0) versus 9.1 (4.8-36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group.
conclusionEFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate. TRIAL REGISTRATION NUMBER: NCT03322553.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.