A randomized trial comparing winged versus conventional plastic stents for malignant bile duct strictures
Autor: | Joel Singer, Terry Lee, Jennifer J. Telford, Eric Lam, Jack Amar, Robert Enns, Ryan Scott, Edward Kim, Danny Cheriyan, Lachlan Ayres, Alan Weiss, Fergal Donnellan, Michael F. Byrne |
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Rok vydání: | 2016 |
Předmět: |
medicine.medical_specialty
Original article medicine.medical_treatment Hilum (biology) law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Medicine Pharmacology (medical) In patient cardiovascular diseases lcsh:RC799-869 Adverse effect Endoscopic retrograde cholangiopancreatography medicine.diagnostic_test business.industry Bile duct strictures Stent equipment and supplies Surgery Clinical trial surgical procedures operative 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology lcsh:Diseases of the digestive system. Gastroenterology business |
Zdroj: | Endoscopy International Open Endoscopy International Open, Vol 05, Iss 07, Pp E635-E641 (2017) |
ISSN: | 2364-3722 |
Popis: | Background and study aims Stent insertion at endoscopic retrograde cholangiopancreatography (ERCP) is an established therapy for managing malignant biliary obstruction. Conventional plastic stents with a tubular design are most commonly used despite limited patency. Plastic stents with a winged design may theoretically increase the duration of stent patency. The aim of this study was to compare stent patency of the winged versus conventional plastic stents in patients with malignant biliary obstruction. Patients and methods A prospective, randomized subject-blinded trial was conducted. Patients with malignant biliary obstruction were randomized (1:1) to either a 10 French winged stent or 7 or 10 French conventional plastic stent. Strictures greater than 1 cm distal to the hilum were included. Patients were followed clinically to determine the frequency of stent failure until surgery, death or study closure. Results Fifty-eight patients were enrolled. Following 9 exclusions, 49 patients were randomized to a winged (n = 23) or conventional stent (n = 26). Median time to stent failure was 89 (95 % CI 26-NA) vs 143 (95 % CI 33 – 266) days (P = 0.963) for the winged and conventional group, respectively. Stent failure for the winged group occurred in 11 (48 %) compared to 14 (54 %) in the conventional group. Median survival was 123 (95 % CI 81 – 189) vs 342 days (95 % CI 123 – 704) (p = 0.084) in the winged and conventional group respectively. There were no procedure related adverse events. Conclusions Improvement in stent patency was not seen with the winged stent when compared to the conventional plastic stent. Clinical trials number NCT01514214. |
Databáze: | OpenAIRE |
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