Original Title: Stents biodegradables para el tratamiento de estenosis esofágicas benignas. Estudio de monitorización

Authors' objectives: The objective of the study was to assess the effectiveness and safety under routine conditions of use of the use of biodegradable stents for the treatment of benign esophageal strictures

Authors' results and conclusions: RESULTS: A total of 20 patients were treated in 9 of the 17 designated centres. The study was closed without having achieved the required sample size and after an extension of 12 months. Among the treated patients the 70% were men and 30% women, and mean age was 55.7 years. The most frequent causes of stricture were anastomosis in 7 cases and radiation in 6 cases. The mean level of dysphagia before the implantation was 2.4. The median location of the stricture was 210 mm from the dental arch to the top of the stricture. The median length of the stricture was 22.5 mm. The following stents were placed: 11 stents of 60 mm, 6 of 80 mm, 1 of 90 mm and 2 of 100 mm in length. Device implantation was successful on the first attempt in 95% of cases. There were 28 adverse events in 14 patients. A 70% of the patients (14) had a severe adverse event. A death, possibly related with the intervention, was registered (5%). The most frequent adverse events were severe nausea and vomiting, severe pain, episodes of complete aphagia requiring either dilation or placement of a metal stent, esophageal perforation, aspiration pneumonia, or mucosal hyperplasia. The number of interventions for the treatment of the esophageal stricture during the 12 months before the intervention decreased by 48.9% in the 12 months after the intervention (p<0.05). The interventions that decreased significantly were dilations, especially balloon dilations, and also metal prostheses implantation. No explanatory variables were identified for the comparison in the number of interventions before and after the implantation. Three months after the implantation a 27.8% of the patients were free of dysphagia. After 6 and 12 months a 31.3% and a 28.6% of the patients were dysphagia free. The mean level of dysphagia according to the Mellow score decreased from 2.39 before the intervention to 1.33, three months after the intervention (p<0.05). After 6 months the decrease was from 2.31 to 1.75 (p=0.1729). After 12 months the decrease was from 2.36 to 1.86 (p=0.3555). Two variables with statistical significance in the evolution of the dysphagia level were identified, as follows: a proximal location of the stricture, and radiation as the cause. Both subgroups of patients had worse outcomes in dysphagia progression throughout the study. CONCLUSIONS • Scarce activity has been observed by the hospitals. They had a much lower number of stent implantations than expected after 3 years and 6 months of recruitment, including a 12-month extension. • The sample size (20 patients), well below that initially required (129 patients), prevents drawing clear conclusions about the safety and effectiveness of the technology. • A greater number of adverse events has been observed than those reported in other studies. It stands out that 70% of patients have suffered some serious adverse event. • The most frequent events have been severe nausea and vomiting, severe pain, episodes of complete aphagia, esophageal perforation, aspiration pneumonia, or mucosal hyperplasia. • Device implantation was successful on the first attempt in 95% of cases. • The percentage of patients free of dysphagia obtained in our study is low compared to that published in systematic reviews. • This study has obtained modest results in terms of reducing the degree of dysphagia. • The reduction in the level of dysphagia observed 3 months after implantation decreases significantly in the follow-ups carried out at 6 and 12 months. • A significant reduction was observed in the number of interventions performed for the treatment of stenosis after the stent implantation. This effect is mainly due to the reduction in the number of balloon dilations. • It is observed that cases with radio-induced stricture and proximal location of the stricture have worse results in terms of the evolution of dysphagia.

Authors' methods: It was a prospective, non-comparative observational study according to the protocol approved on February 2017 (annex). The evaluated device was the esophageal biodegradable stent SX-ELLATM. The inclusion critera were benign esophageal stenosis, a level of dysphagia equal to or greater than 2 according to the Mellow score, and failure of the standard of care. Failure was defined as at least three interventions to treat the esophageal stricture (dilations and/or prosthesis) without success in the last year. Success was defined as a decrease in the dysphagia level of two points in the Mellow score between the level before and after the intervention, with this decrease being maintained at least four weeks after the intervention. The safety and effectiveness of the technology were assessed with follow-ups at 3, 6 and 12 months after the intervention. The safety assessment was done through a descriptive study of the following outcomes: • Adverse events measuring perioperative and follow-up complications. • Failure or complications during the implantation. • Hospital admission for the implantation procedure. • Procedure related mortality. The effectiveness assessment was done through a descriptive and an analytic study of the following outcomes: • Dysphagia level according to the Mellow score. • Patients free of dysphagia after the intervention. • Number of interventions performed to treat the esophageal stricture. • The analytical study compared the number of interventions and dysphagia level before and after the stent implantation (measured at 3, 6 and 12 months).

Project Status: Completed

Year Published: 2024

URL for published report: https://repisalud.isciii.es/handle/20.500.12105/18531

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Agencia de Evaluacion de Tecnologias Sanitarias

Contact Address: Instituto de Salud "Carlos III", Calle Sinesio Delgado 6, Pabellon 4, 28029 Madrid, Spain. Tel: +34 9 1 822 2005; Fax: +34 9 1 387 7841;

Contact Name: Luis M. Sánchez Gómez

Contact Email: luism.sanchez@isciii.es

Copyright: <p>Agencia de Evaluacion</p>