Gastrointestinal endoscopy · 2025
Preliminary feasibility study of a novel spiral-designed plastic stent for endoscopic management of malignant hilar biliary obstruction: a multicenter prospective study (with video).
СтатьяМногоцентровое исследованиеVideo-Audio MediaПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Lee Kyong Joo, Park Se Woo, Park Da Hae, Cha Hye Won, Koh Dong Hee, Lee Jin, Cho Eunae
Аннотация
BACKGROUND AND AIMS: Plastic stents (PSs) are widely used for palliative drainage in patients with malignant hilar obstruction (MHO); however, their clinical utility is often limited by their short duration of patency, occlusion, and the risk of migration. This study aimed to evaluate the feasibility, safety, and clinical efficacy of a newly designed Twist stent (Taewoong Medical Co, Ltd, Goyang, South Korea) PS, specifically designed to enhance anchoring and prolong patency during endoscopic MHO treatment.
METHODS: This prospective study enrolled 32 patients with MHO who underwent endoscopic retrograde cholangiopancreatography with placement of an 8.5F Twist PS. The primary endpoint was the 3-month stent patency, defined as the absence of dysfunction, including occlusion or migration. The secondary endpoints encompassed technical and clinical success rates, as well as the incidence of adverse events.
RESULTS: Technical and clinical success rates were 96.9% and 84.4%, respectively. Bilateral stent placement was performed in 53.1% (17/32) of the cases, all with a 100% technical success rate. The 3-month stent patency rate was 76.9%, and the median duration of stent patency was 146.0 days (95% CI, 122.7-169.3 days). No cases of spontaneous stent migration were observed during a median follow-up period of 225.0 days. Sludge formation was the most common cause of late stent dysfunction and occurred in 28.1% of patients.
CONCLUSIONS: The newly designed Twist PS exhibited high technical success and sustained patency in the management of MHO, with a 3-month stent patency rate of 76.9% and no observed instances of spontaneous migration. These findings highlight its potential role in optimizing biliary drainage.
METHODS: This prospective study enrolled 32 patients with MHO who underwent endoscopic retrograde cholangiopancreatography with placement of an 8.5F Twist PS. The primary endpoint was the 3-month stent patency, defined as the absence of dysfunction, including occlusion or migration. The secondary endpoints encompassed technical and clinical success rates, as well as the incidence of adverse events.
RESULTS: Technical and clinical success rates were 96.9% and 84.4%, respectively. Bilateral stent placement was performed in 53.1% (17/32) of the cases, all with a 100% technical success rate. The 3-month stent patency rate was 76.9%, and the median duration of stent patency was 146.0 days (95% CI, 122.7-169.3 days). No cases of spontaneous stent migration were observed during a median follow-up period of 225.0 days. Sludge formation was the most common cause of late stent dysfunction and occurred in 28.1% of patients.
CONCLUSIONS: The newly designed Twist PS exhibited high technical success and sustained patency in the management of MHO, with a 3-month stent patency rate of 76.9% and no observed instances of spontaneous migration. These findings highlight its potential role in optimizing biliary drainage.