Trial reportThe American journal of gastroenterology2012
A double-blind sham-controlled study of the effect of radiofrequency energy on symptoms and distensibility of the gastro-esophageal junction in GERD.
Trial report in The American journal of gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 5 of them syntheses that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
54 citing papers in PubMed, 5 syntheses or guidelines pooled it, 127 citations in OpenAlex.
- Pooled it
- Efficacy of different endoscopic treatments in patients with gastroesophageal reflux disease: a systematic review and network meta-analysis.Surgical endoscopy · 2021Pooled it
- Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease.Surgical endoscopy · 2017Pooled it
- Randomized sham-controlled trials in endoscopy: a systematic review and meta-analysis of adverse events.Gastrointestinal endoscopy · 2017Pooled it
- Use of placebo controls in the evaluation of surgery: systematic review.BMJ (Clinical research ed.) · 2014Pooled it
- Radiofrequency energy delivery to the lower esophageal sphincter improves gastroesophageal reflux patient-reported outcomes in failed laparoscopic Nissen fundoplication cohort.Surgical endoscopy · 2017Trial
- Role of radiofrequency STRETTA for recurrent GERD following primary anti-reflux surgery and primary STRETTA therapy.Surgical endoscopy · 2025Article
- 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
- 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
- Endoscopic Advances in the Diagnosis and Management of Gastroesophageal Reflux Disease.Medicina (Kaunas, Lithuania) · 2024Review
- Endoscopic Non-ablative Radiofrequency Treatment (Stretta) for Gastroesophageal Reflux Disease (GERD).Current gastroenterology reports · 2024Review
- Refractory Gastroesophageal Reflux Disease: Diagnosis and Management.Journal of neurogastroenterology and motility · 2024Review
- Endoscopic radiofrequency Stretta therapy reduces proton pump inhibitor dependency and the need for anti-reflux surgery for refractory gastroesophageal reflux disease.Clinical endoscopy · 2024Article
- Endoscopic versus surgical therapies for GERD: a systematic review and network meta-analysis.iGIE : innovation, investigation and insights · 2023Article
- Randomized Controlled Trial of Anti-reflux Mucosectomy Versus Radiofrequency Energy Delivery for Proton Pump Inhibitor-refractory Gastroesophageal Reflux Disease.Journal of neurogastroenterology and motility · 2023Article
- Endoscopic interventions in the management of the gastroesophageal reflux: a narrative review.Annals of esophagus · 2023Article
- Multi-society consensus conference and guideline on the treatment of gastroesophageal reflux disease (GERD).Surgical endoscopy · 2023Article
- Role of Endoscopy in Motility Disorders of Upper Gastrointestinal Tract.Journal of neurogastroenterology and motility · 2023Review
- Is patient satisfaction sufficient to validate endoscopic anti-reflux treatments?World journal of gastroenterology · 2022Article
Corrections and comments
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Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesSeveral studies have reported symptom relief in gastro-esophageal reflux disease (GERD) patients treated with radiofrequency delivery (Stretta procedure) at the gastro-esophageal junction (GEJ), but the mechanism underlying this improvement is unclear. The objective of this study was to test the hypothesis that Stretta alters GEJ resistance.
methodsWe conducted a double-blind randomized cross-over study of Stretta and sham treatment. Consecutive GERD patients were included in the study. The study was conducted in a tertiary care center. Patients underwent two upper gastrointestinal endoscopies with 3 months interval, during which active or sham Stretta treatment was performed in a randomized double-blind manner. Symptom assessment, endoscopy, manometry, 24-h esophageal pH monitoring, and a distensibility test of the GEJ were done before the start of the study and after 3 months.
resultsBarostat distensibility test of the GEJ before and after administration of sildenafil was the main outcome measure. In all, 22 GERD patients (17 females, mean age 47±12 years) participated in the study; 11 in each group. Initial sham treatment did not affect any of the parameters studied. Three months after initial Stretta procedure, no changes were observed in esophageal acid exposure and lower esophageal sphincter (LES) pressure. In contrast, symptom score was significantly improved and GEJ compliance was significantly decreased. Administration of sildenafil, an esophageal smooth muscle relaxant, normalized GEJ compliance again to pre-Stretta level, arguing against GEJ fibrosis as the underlying mechanism.
conclusionsThe limitation of this study was reflux evaluation did not include impedance monitoring. In this sham-controlled study, Stretta improved GERD symptoms and decreased GEJ compliance. Decreased GEJ compliance, which reflects altered LES neuromuscular function, may contribute to symptomatic benefit by decreasing refluxate volume.
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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.