Danish medical journal · 2025
Nitroglycerin for oesophageal food impaction: protocol for a double-blind, randomised clinical trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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de Paiva Christina Resende, Ranneries Trine Nybo, Barfred Mathias, Lynggaard Charlotte Duch, Andreasen Kristian, Jørskov Andreas P Schjellerup, Howitz Michael F, Kirchmann Malene
Аннотация
INTRODUCTION: Oesophageal food impaction (EFI) is a common and potentially serious condition where a piece of food becomes lodged in the oesophagus. No significantly effective pharmacological treatment exists. Nitroglycerin (NTG) is a potent vasodilator that might induce sufficient smooth muscle relaxation to resolve the EFI. We aim to evaluate the efficacy and safety of NTG in EFI treatment.
METHODS: The study is an investigator-initiated, double-blind, multicentre, randomised, placebo-controlled, parallel-arm trial to assess the efficacy, safety and feasibility of NTG for patients with EFI. The study targets patients > 18 years of age with EFI. Patients will be randomised (1:1) to receive either oral NTG dissolved in 10 of ml tap water or oral placebo dissolved in 10 ml of tap water for up to two administrations separated by at least 30 minutes. The treatment resolves the food impaction if the patient can drink and eat afterwards.
CONCLUSION: The results of the study may guide future research and provide evidence for a pharmacological treatment option for oesophageal food impaction.
FUNDING: Fru Olga Bryde Nielsens Fond. The funding source had no influence on the trial design, data collection, analysis or publication of the paper.
TRIAL REGISTRATION: European Union Clinical Trials Register, EU trial number: 2023-503983-17-00. Authorisation date 28082023.
METHODS: The study is an investigator-initiated, double-blind, multicentre, randomised, placebo-controlled, parallel-arm trial to assess the efficacy, safety and feasibility of NTG for patients with EFI. The study targets patients > 18 years of age with EFI. Patients will be randomised (1:1) to receive either oral NTG dissolved in 10 of ml tap water or oral placebo dissolved in 10 ml of tap water for up to two administrations separated by at least 30 minutes. The treatment resolves the food impaction if the patient can drink and eat afterwards.
CONCLUSION: The results of the study may guide future research and provide evidence for a pharmacological treatment option for oesophageal food impaction.
FUNDING: Fru Olga Bryde Nielsens Fond. The funding source had no influence on the trial design, data collection, analysis or publication of the paper.
TRIAL REGISTRATION: European Union Clinical Trials Register, EU trial number: 2023-503983-17-00. Authorisation date 28082023.