2021
DOI: 10.1016/j.clon.2020.12.010
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A Phase II Study of Biodegradable Stents Plus Palliative Radiotherapy in Oesophageal Cancer

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Cited by 4 publications
(2 citation statements)
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“…The role of BDS in the management of malignant esophageal strictures is not adequately defined, and in such scenarios, BDS is not yet considered a valid alternative to SEMS. Studies have evaluated outcomes of BDS in patients undergoing single dose brachytherapy [20], palliative radiotherapy [21], and neoadjuvant treatment or radical radiotherapy [22], but in each of these studies, despite adequate technical success and short-term dysphagia symptom improvement, unacceptably high rates of adverse events and complications (retrosternal pain, vomiting, epithelial hyperplasia, and stent-related death), stent dysfunction, and need for reintervention were reported [20][21][22]. To overcome these limitations, BDS using novel materials (elastic and biodegradable mixed polymer of Poly(ε-caprolactone) (PCL) and poly(tri-methylene carbonate) (PTMC) as the coated membrane on magnesium alloy stents) are being developed but have not yet been tested in humans [23,24].…”
Section: Biodegradable Stentsmentioning
confidence: 99%
“…The role of BDS in the management of malignant esophageal strictures is not adequately defined, and in such scenarios, BDS is not yet considered a valid alternative to SEMS. Studies have evaluated outcomes of BDS in patients undergoing single dose brachytherapy [20], palliative radiotherapy [21], and neoadjuvant treatment or radical radiotherapy [22], but in each of these studies, despite adequate technical success and short-term dysphagia symptom improvement, unacceptably high rates of adverse events and complications (retrosternal pain, vomiting, epithelial hyperplasia, and stent-related death), stent dysfunction, and need for reintervention were reported [20][21][22]. To overcome these limitations, BDS using novel materials (elastic and biodegradable mixed polymer of Poly(ε-caprolactone) (PCL) and poly(tri-methylene carbonate) (PTMC) as the coated membrane on magnesium alloy stents) are being developed but have not yet been tested in humans [23,24].…”
Section: Biodegradable Stentsmentioning
confidence: 99%
“… Yano et al (2017) confirmed that BDS is an efficient and well-tolerated therapeutic choice for RBES that occurs after esophageal cancer treatment, particularly following ESD or CRT; however, its long-term efficacy remains limited. In 2021, Maishman et al (2021) employed the SIMON two-stage, single-arm, prospective phase II trial design to assess the efficacy of biodegradable stents in combination with radiotherapy in patients with esophageal cancer-related dysphagia who were not candidates for radical interventions. The observed elevated intervention rates indicate that the proposed alternative treatments may not be sufficiently efficacious to justify their inclusion in larger-scale trial designs.…”
Section: Materials Used In Biodegradable Esophageal Stentsmentioning
confidence: 99%