SX-ELLA biodegradable stent for benign oesophageal strictures: a systematic review and proportion meta-analysis

Abstract

Background This systematic review aimed to analyse the use of the SX-ELLA biodegradable stent (BDS) for benign oesophageal strictures through the assessment of clinical and technical success, differences in pre- and post-BDS insertion dysphagia scores, rates of stent migration, and safety. Methods A systematic review was reported according to PRISMA guidelines, with a prospectively registered protocol. The databases PubMed, Embase, SCOPUS, and ClinicalTrials.gov were searched up to March 2022. Studies assessing the use of the SX-ELLA BDS in adults with benign oesophageal strictures were included. A pooled data analysis was conducted to analyse the clinical and technical success associated with BDS use, rate of stent migration, and safety. Results Of the 1509 articles identified, 16 studies treating 246 patients were eligible for inclusion. BDS was clinically successful in 41.9% of cases (95% CI = 35.7 – 48.1%), defined as those who experienced complete symptom resolution following BDS insertion. Technical success was achieved in 97.2% of patients (95% CI = 95.1 – 99.3%). A pooled analysis concluded a decrease in mean dysphagia score of 1.8 points (95% CI = 1.68 – 1.91) following BDS insertion. Re-intervention was required in 89 patients (36.2%, 95% CI = 30.2 – 42.2%), whilst stent migration occurred in 6.5% of patients (95% CI = 3.4 – 9.6%). A total of 37 major clinical complications related to BDS insertion were reported (15.0%, 95% CI = 10.5 – 19.5%). Conclusion The pooled data analysis demonstrates the high technical and moderate clinical success of the SX-ELLA biodegradable stent, supporting its use for benign oesophageal strictures in adults. However, greater evidence is required for more robust conclusions to be made in terms of success when compared to alternative methods of intervention, such as endoscopic dilation.

Comprehensive review of materials, applications, and future innovations in biodegradable esophageal stents

“…In summary, ELLa-BDS demonstrates remarkable flexibility and biocompatibility. As previously mentioned, multiple studies have consistently confirmed the safety and efficacy of ELLa-BDS (van Boeckel et al, 2011;van Hooft et al, 2011;Hirdes et al, 2012a;McCain et al, 2016;Walter et al, 2018;Kailla et al, 2023). ELLa-BDS exhibited more promising results than PLLA-BDS, with a notably low migration rate (Dhar et al, 2009;van Boeckel et al, 2011;van Hooft et al, 2011;Yang et al, 2016).…”

“…In 2022, a non-randomized, single-arm prospective trial ( Yano et al, 2022 ) conducted across eight institutions provided compelling evidence that ELLa-BDS was indeed effective in treating RBES and demonstrated a satisfactory safety profile. Furthermore, a recent systematic review and proportion meta-analysis conducted by Kailla et al (2023) in 2023 demonstrated that ELLa-BDS’s high technical sophistication and moderate clinical efficacy support its use in the management of adult BES. However, further evidence is required to substantiate its advantage over alternative approaches such as endoscopic dilation.…”