ArticleSurgical endoscopy2012
Comprehensive evaluation of endoscopic fundoplication using the EsophyX™ device.
Article in Surgical endoscopy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 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
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Efficacy of transoral incisionless fundoplication (TIF) for the treatment of GERD: a systematic review with meta-analysis.Surgical endoscopy · 2017Pooled it
- Impact of transoral incisionless fundoplication (TIF) on subjective and objective GERD indices: a systematic review of the published literature.Surgical endoscopy · 2013Pooled it
- Randomized controlled trial of transoral incisionless fundoplication vs. proton pump inhibitors for treatment of gastroesophageal reflux disease.The American journal of gastroenterology · 2015Trial
- 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
- Clinical efficacy and safety of magnetic sphincter augmentation (MSA) and transoral incisionless fundoplication (TIF2) in refractory gastroesophageal reflux disease (GERD): a systematic review and meta-analysis.Endoscopy international open · 2021Review
- The evolution of TIF: transoral incisionless fundoplication.Therapeutic advances in gastroenterology · 2020Review
- Review of antireflux procedures for proton pump inhibitor nonresponsive gastroesophageal reflux disease.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2017Review
- [Surgical and interventional procedures for reflux therapy : Endoscopic or laparoscopic?]Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen · 2017Review
- Transoral incisionless fundoplication for gastro-esophageal reflux disease: Techniques and outcomes.World journal of gastrointestinal pharmacology and therapeutics · 2016Review
- Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study.Surgical endoscopy · 2015Article
- Developments in flexible endoscopic surgery: a review.Clinical and experimental gastroenterology · 2015Review
- Univariate and multivariate analyses of preoperative factors influencing symptomatic outcomes of transoral fundoplication.Surgical endoscopy · 2014Article
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 at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere are limited studies that evaluate the efficacy of endoscopic fundoplication (EF) for gastroesophageal reflux disease (GERD) with the EsophyX™ device, especially with the most recent procedural iteration (TIF-2). This study was a prospective evaluation of our early experience with this device and procedure.
methodsData were collected prospectively on 23 consecutive patients undergoing EF (March 2009 to August 2010). All patients completed a symptom questionnaire assessing frequency and severity of gastrointestinal and respiratory symptoms, 24-h pH, and manometry studies preoperatively and were encouraged to repeat these at 6 months.
resultsAll patients had abnormal pH studies and were on proton-pump inhibitor (PPI) therapy prior to EF. Median age was 47 years (19-62 years), and six (23%) were male. Nine (41%) patients had Body Mass Index (BMI) ≥ 30 kg/m(2), and three (14%) had a small hiatal hernia (≤ 2 cm). The procedure was aborted in two patients for retained food. Three patients underwent subsequent laparoscopic Nissen fundoplication for persistent or recurrent symptoms. Median hospitalization was 1 day, and there were no major perioperative complications. At 6 month follow-up, 19 (86%) patients completed a symptom questionnaire, and 14 (64%) and 11 (50%) patients underwent pH and manometry studies, respectively. There was a significant reduction in heartburn (P = 0.02), total percentage acid contact time (P = 0.002), DeMeester score (P = 0.002), and PPI use (P = 0.003). Overall, 8 out of 14 (57%) patients had abnormal pH studies and 11 out of 19 (58%) remained on PPI therapy at 6 months.
conclusionEF with EsophyX™ is associated with significant reduction in heartburn and abnormal acid exposure at 6 months, although the majority of patients did not experience normalization of their pH studies and remained on PPI therapy. The procedure has an acceptable safety profile, but the question remains as to whether it is effective enough to warrant a place in the armamentarium for the treatment of GERD.
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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.