Evidence map›Paper›PMID 25480624›Full record

ArticleSurgical endoscopy2015

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.

Pier Alberto Testoni, Sabrina Testoni, Giorgia Mazzoleni, Cristian Vailati, Sandro Passaretti

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Surgical endoscopy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05365087 (The Effect of Endoscopic Fundoplication Prior to Sleeve Gastrectomy Versus Gastric Bypass on Reflux Symptoms in Bariatric Patients With Gastroesophageal Reflux Disease), which is not on this map. Cited by 48 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 2 pooled it
6.3field-weighted citation impact, top 3% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT05365087 active not recruitingnot on this mapstarted 2018, after this paper: background citation

The Effect of Endoscopic Fundoplication Prior to Sleeve Gastrectomy Versus Gastric Bypass on Reflux Symptoms in Bariatric Patients With Gastroesophageal Reflux Disease

TypeobservationalSponsorLexington Health IncorporatedRan2018 to 2032Enrolled180ConditionsGastroesophageal Reflux DiseaseArmsTransoral Fundoplication and Sleeve Gastrectomy, Gastric Bypass
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 2 syntheses or guidelines pooled it, 114 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Transoral incisionless fundoplication as rescue therapy for gastroesophageal reflux in a lung transplant recipient.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2025
    Article
  9. 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 · 2025
    Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Functional outcomes of hybrid hiatal hernia repair.Journal of robotic surgery · 2023
    Article
  17. Article
  18. Article
  19. Endoscopic Management of GERD.Digestive diseases and sciences · 2022
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Pier Alberto TestoniUnit of Gastroenterology and Gastrointestinal Endoscopy, Division of Experimental Oncology, IRCCS San Raffaele Scientific Institute - Vita-Salute San Raffaele University, Milan, Italy, testoni.pieralberto@hsr.it.
Sabrina Testoni
Giorgia Mazzoleni
Cristian Vailati
Sandro Passaretti
Vita-Salute San Raffaele University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTransoral incisionless fundoplication (TIF) with the EsophyX™ device creates an antireflux valve with good functional results in patients with gastro-esophageal reflux disease (GERD). The aim of this study was to assess the long-term effect of TIF 2.0 on pathological reflux and symptoms in GERD patients with daily dependence on proton pump inhibitors (PPI).

methodsFifty patients underwent TIF. All underwent GERD-HRQL and GERD-QUAL questionnaires, upper GI endoscopy, esophageal manometry, and 24-h pH-impedance before and 6, 12, and 24 months after TIF, and subsequent yearly clinical re-evaluation.

resultsPatients were followed for up to six years (mean 52.7 ± 19.7 months). In all, 83.7, 79.6, 87.8, and 84.4% of patients stopped or halved the PPI therapy 6, 12, 24, and 36 months after TIF. Three-year figure remained stable up to 6 years. Symptom scores off PPI were significantly lower at 6, 12, 24, and 36 months. At 6 months, Hill's grade I of the newly created valve persisted in all pre-procedure Hill's grade I patients, in 66.7% of grade II and 58.3% of grade III. This figure remained substantially unchanged at 12 and 24 months, too. Impedance monitoring indicated significantly fewer total and acid refluxes after treatment (p = 0.01). Factors predicting good outcomes were pre-procedure Hill's grade I-II, no hiatal hernia or hernia ≤2 cm (p = 0.03), absence of ineffective esophageal motility (p < 0.0001), and number of fasteners deployed (p = 0.01).

conclusionsTIF by the EsophyX achieved lasting elimination of daily dependence on PPI in 75-80% of patients for up to 6 years. TIF seems an effective therapy for selected symptomatic GERD patients.

Indexed as

AdultEsophageal pH MonitoringFemaleFollow-Up StudiesFundoplicationGastroesophageal RefluxHumansMaleManometryMiddle AgedProspective StudiesProton Pump InhibitorsQuality of LifeSurveys and QuestionnairesTreatment OutcomeProton Pump Inhibitors

Identifiers

PMID25480624
OpenAlexW2016049902

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.