European TIF2.0 Registry

Официальное название

Prospective Evaluation of the Safety and Efficacy of Transoral Incisionless Fundoplication 2.0 in the Management of Reflux: a European Registry

Обзор

This is a European, multi-centre, prospective registry that aims to determine the safety and efficacy of transoral incisionless fundoplication, with or without concomitant hiatal hernia repair, for the treatment of patients with gastro-oesophageal reflux disease (GORD).

Вмешательства

• Устройство Transoral incisionless fundoplication with or without concomitant hiatal hernia repair with the EsophyX device
  Transoral Incisionless Fundoplication (TIF): The TIF procedure is an endoscopic, minimally invasive intervention designed to reconstruct the gastro-oesophageal valve and restore its function as a reflux barrier, without external incisions. The procedure is performed transorally using the EsophyX device under general anaesthesia. The device enables the creation of a 270° to 300° esophagogastric fundoplication. Concomitant TIF (cTIF): The cTIF procedure combines a laparoscopic hiatal hernia rep

Первичные конечные точки

• Gastroesophageal reflux disease health-related quality of life questionnaire (GERD-HRQL) [Срок оценки: 6-months, 1-year, 2-year, 3-years, 5-, years]
• Reflux symptom index (RSI) [Срок оценки: 6-months, 1-year, 2-years, 3-years, 5-years]
• Proton pump inhibitor and/or histamine-2 receptor antagonist use [Срок оценки: 6-months, 1-year, 2-years, 3-years, 5-years]

Вторичные конечные точки (7)

• Physiological reflux testing [Срок оценки: up to 5-years]
• Procedural outcomes (technical success) [Срок оценки: 30-days]
• Procedural outcomes (duration) [Срок оценки: 30-days]
• Procedural outcomes (length of hospital stay [Срок оценки: 30-days]
• Adverse events [Срок оценки: up to 30-days]
• Adverse events of special interest [Срок оценки: Up to 5-years]
• Need for revisional procedure [Срок оценки: Up to 5-years]

Критерии участия

Критерии включения

• Any adult patient (≥18 years old) undergoing TIF2.0 or cTIF, at a participating centre, who can understand and sign the informed consent form, and is conducted in line with local institutional review board approval and recommendations.

Критерии исключения

• There are no specific exclusion criteria.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австрия · 1 центр

• Department of General Surgery, Medical University of Vienna — Vienna

Италия · 1 центр

• Gemelli Isola — Rome

Сербия · 1 центр

• University Hospital for Digestive Surgery — Belgrade

Швейцария · 1 центр

• Intesto — Bern

Turkey (Türkiye) · 1 центр

• Memorial bahçelievler hospital — Istanbul

ОАЭ · 1 центр

• Cleveland Clinic — Abu Dhabi

Великобритания · 1 центр

• Cleveland Clinic London — London

Публикации

• Testoni S, Hassan C, Mazzoleni G, Antonelli G, Fanti L, Passaretti S, Correale L, Cavestro GM, Testoni PA. Long-term outcomes of transoral incisionless fundoplication for gastro-esophageal reflux disease: systematic-review and meta-analysis. Endosc Int Open. 2021 Feb;9(2):E239-E246. doi: 10.1055/a-1322-2209. Epub 2021 Feb 3. PMID 33553587
• Demartini B, Nistico V, D'Agostino A, Priori A, Gambini O. Early Psychiatric Impact of COVID-19 Pandemic on the General Population and Healthcare Workers in Italy: A Preliminary Study. Front Psychiatry. 2020 Dec 22;11:561345. doi: 10.3389/fpsyt.2020.561345. eCollection 2020. PMID 33414728
• Cristol DA, Evers DC. The impact of mercury on North American songbirds: effects, trends, and predictive factors. Ecotoxicology. 2020 Oct;29(8):1107-1116. doi: 10.1007/s10646-020-02280-7. Epub 2020 Sep 24. PMID 32970279
• Rahimi Z, Ghorbani-Shahna F, Bahrami A. Design, Implementation, and Evaluation of Industrial Ventilation Systems and Filtration for Silica Dust Emissions from a Mineral Processing Company. Indian J Occup Environ Med. 2021 Oct-Dec;25(4):192-197. doi: 10.4103/ijoem.IJOEM_55_19. Epub 2021 Dec 31. PMID 35197669
• Globig P, Willumeit-Romer R, Martini F, Mazzoni E, Luthringer-Feyerabend BJC. Slow degrading Mg-based materials induce tumor cell dormancy on an osteosarcoma-fibroblast coculture model. Bioact Mater. 2021 Dec 30;16:320-333. doi: 10.1016/j.bioactmat.2021.12.031. eCollection 2022 Oct. PMID 35386318
• Jaruvongvanich VK, Matar R, Reisenauer J, Janu P, Mavrelis P, Ihde G, Murray M, Singh S, Kolb J, Nguyen NT, Thosani N, Wilson EB, Zarnegar R, Chang K, Canto MI, Abu Dayyeh BK. Hiatal hernia repair with transoral incisionless fundoplication versus Nissen fundoplication for gastroesophageal reflux disease: A retrospective study. Endosc Int Open. 2023 Jan 4;11(1):E11-E18. doi: 10.1055/a-1972-9190. eC PMID 36618876
• Mattei C, Tricoire-Leignel H, Legros C, Lewis RJ, Molgo J. Editorial: Pharmacological Aspects of Ligand-Gated Ion Channels as Targets of Natural and Synthetic Agents. Front Neurosci. 2022 Apr 8;16:895299. doi: 10.3389/fnins.2022.895299. eCollection 2022. No abstract available. PMID 35464319

Идентификаторы

NCT: NCT07395219 · CCL-2021-TIF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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