Gastroenterologia y hepatologia · 2025
Subjective evaluation by expert endoscopists in on-label indications of a novel cautery-tipped lumen-apposing metal stent with a conventional delivery system (Hot-Spaxus©): a pilot study.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Martinez-Ortega Antonio, de Benito Sanz Marina, García Alonso Francisco J, Latras Cortés Irene, Aparicio Tormo José Ramón, Sanchiz Soler Vicente, Gornals Joan B, Subtil Iñigo José Carlos, Martínez Moreno Belén, Sumalla-Garcia Albert, Sánchez Ocaña Ramón, de la Serna-Higuera Carlos, Perez-Miranda Manuel
Аннотация
AIM: To evaluate the potential acceptance of Hot-Spaxus in routine practice through a subjective technical assessment by expert endoscopists, and to assess its short-term efficacy and safety.
PATIENTS AND METHODS: Observational multicenter study based on a prospective database of the first cases of EUS-guided therapeutic drainage of on-label targets (pancreatic fluid collections [PFC] and gallbladder drainage [GD]) using Hot-Spaxus© doing by 6 expert endoscopist. After the endoscopic procedure, experts completed two questionnaires with 9 items each: one assessing technical difficulty and another evaluating preference for Hot-Spaxus, Hot-Axios, or no preference/similar.
RESULTS: Twelve patients were included (4 PFC / 8 GD); 66% were women, with a median age of 84.8 years (IQR 71.7-89.4). In the questionnaire on perceived difficulty, most items were rated as easy or moderate, while the "very difficult" category was reported infrequently. Endoscopists preferred Hot-Axios© over Hot-Spaxus© regarding position control during deployment (58.3%) and management of the delivery system (58.3%). Technical and clinical success rates were 91.7% and 90.9%, respectively. One case of bleeding was reported as an adverse event (8.3%).
CONCLUSIONS: Deployment system friction, endoscope channel friction, and guidewire passage through the delivery system were perceived as less complex. In contrast, penetration, position control, and LAMS deployment were considered more challenging and were rated less favorably compared with Hot-Axios©.
PATIENTS AND METHODS: Observational multicenter study based on a prospective database of the first cases of EUS-guided therapeutic drainage of on-label targets (pancreatic fluid collections [PFC] and gallbladder drainage [GD]) using Hot-Spaxus© doing by 6 expert endoscopist. After the endoscopic procedure, experts completed two questionnaires with 9 items each: one assessing technical difficulty and another evaluating preference for Hot-Spaxus, Hot-Axios, or no preference/similar.
RESULTS: Twelve patients were included (4 PFC / 8 GD); 66% were women, with a median age of 84.8 years (IQR 71.7-89.4). In the questionnaire on perceived difficulty, most items were rated as easy or moderate, while the "very difficult" category was reported infrequently. Endoscopists preferred Hot-Axios© over Hot-Spaxus© regarding position control during deployment (58.3%) and management of the delivery system (58.3%). Technical and clinical success rates were 91.7% and 90.9%, respectively. One case of bleeding was reported as an adverse event (8.3%).
CONCLUSIONS: Deployment system friction, endoscope channel friction, and guidewire passage through the delivery system were perceived as less complex. In contrast, penetration, position control, and LAMS deployment were considered more challenging and were rated less favorably compared with Hot-Axios©.