{
  "abstract": "Introduction Transoral Incisionless Fundoplication (TIF2.0) is an endoscopic procedure for the management of gastro-oesophageal reflux disease (GORD) using the EsophyX device. TIF2.0 is currently endorsed by the American Society of Gastrointestinal Endoscopy as a mechanical option for patients with proven GORD. We report on the largest dataset outside North America on the safety and efficacy of TIF2.0 conducted within the European TIF registry (EURO-TIF).Methods A prospective, multi-centre registry conducted across seven European centres and registered at Cleveland Clinic London (CCL-2021-TIF). All patients undergoing TIF2.0 for GORD since 2021 were eligible for inclusion. Primary outcomes were change in reflux-specific quality of life questionnaire (GERD-HRQL) and acid suppression use from baseline to 24-months follow-up. Secondary outcomes included procedural outcomes, changes in oesophageal physiological parameters, and adverse events (AGREE classification). Within-patient changes were analysed using paired t-tests and a linear mixed-effects model.Results In total, 261 patients underwent TIF 2.0, with outcome data available for 192 (median age 47 years [IQR 36–56], 38.5% female). Most were treatment naïve (97.4%, n=187), with 91.1% (n=175) receiving regular anti-acid therapy. Hiatus hernia was present in 51.9% (n=97; median size 1 cm [IQR 1–2]). Baseline physiological testing was conducted in 161 patients (wireless capsule in 52.5% [n=85]), which showed an average acid exposure time (AET) of 10.1% (IQR 6.8-15.3), total reflux episodes of 86.3 (SD 52.8; catheter-based), and average daily reflux episodes of 58.2 (SD 21.7; wireless). Average GERD-HRQL score at baseline was 19.2 (SD 11.7; n=171) with a dissatisfaction score in 81.4% (n=140). Technical success was 99.5% (n=191) with an average procedure time of 39.0 minutes (SD 11.5), 14 pairs of plications (IQR 10-14) and 1-day inpatient stay (IQR 1). Within 30-days, 18 adverse events occurred (12 AGREE I, 3 AGREE II, and 3 AGREE IIIa). The most severe being bleeding at the site of fundoplication (n=3). At 6-, 12-, and 24-months post-procedure, 78.6% (n=151), 53.6% (n=103), and 18.2% (n=35) were available for follow-up. The average GERD-HRQL was 3.9 (95% CI; 2.7-5.1; p<0.001), 4.0 (95% CI 2.8-5.3; p<0.001), and 3.5 (95% CI 0.7-6.2; p=0.01), which corresponded to a mean within patient reduction of -13.5 (SD 10.0; p<0.001), -14.2 (SD 10.5; p<0.001), and -23.1 (SD 14.5; p<0.01), respectively. Discontinuation of anti-acid therapy occurred in 84.5%, 85.3%, and 84.6% of patients at the same time points. Among patients undergoing repeat physiological testing, mean AET was significantly reduced at 6 months (2.3%; n=24; p<0.001) and 12 months (4.5%; n=21; p=0.01).Conclusions This large international registry demonstrates that TIF 2.0 is associated with a favourable safety profile and clinically meaningful symptomatic and physiological improvements in GORD.",
  "authors": [
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom",
        "University College London, London, United Kingdom"
      ],
      "name": "Benjamin Norton"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom",
        "University College London, London, United Kingdom"
      ],
      "name": "Andrea Telese"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Sundas Hasan"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Alana Stevens"
    },
    {
      "affiliations": [
        "Gastroenterology Service Intesto, Bern, Switzerland"
      ],
      "name": "Anne-Sophie Jasawant"
    },
    {
      "affiliations": [
        "University of Bern, Bern, Switzerland"
      ],
      "name": "Henrik Weber"
    },
    {
      "affiliations": [
        "Ospedale Isola Tiberina Gemelli Isola, Rome, Italy"
      ],
      "name": "Milutin Bulajic"
    },
    {
      "affiliations": [
        "Ospedale Isola Tiberina Gemelli Isola, Rome, Italy"
      ],
      "name": "Salvatore F Vadalà di Prampero"
    },
    {
      "affiliations": [
        "Teknon Medical Center, Barcelona, Spain"
      ],
      "name": "Rocío Temiño"
    },
    {
      "affiliations": [
        "Teknon Medical Center, Barcelona, Spain"
      ],
      "name": "Román Turró"
    },
    {
      "affiliations": [
        "Universitätsklinik für Allgemeinchirurgie, Vienna, Austria",
        "Klinische Abteilung für Viszeralchirurgie, Vienna, Austria"
      ],
      "name": "Sebastian Schoppmann"
    },
    {
      "affiliations": [
        "Memorial Bahçelievler Hastanesi, İstanbul, Turkey"
      ],
      "name": "Salih Boğa"
    },
    {
      "affiliations": [
        "University Clinical Center of Serbia, Belgrade, Serbia"
      ],
      "name": "Ognjan M Skrobic"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "David Monk"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Sacheen Kumar"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Borzoueh Mohammadi"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Muntzer Mughal"
    },
    {
      "affiliations": [
        "University Clinical Center of Serbia, Belgrade, Serbia"
      ],
      "name": "Aleksandar Simic"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hôpital Fribourgeois, Bern, Switzerland"
      ],
      "name": "Dominic Staudenmann"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Rehan Haidry"
    }
  ],
  "title": "O81 Transoral incisionless fundoplication for gastro-oesophageal reflux disease: first results from the European TIF registry (EURO-TIF)",
  "uid": "040d115c-604c-5791-8df0-83cb9804812f"
}