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Outcomes of Spiral Versus Conventional Double Pigtail Plastic Stents in Permanent Transpapillary Gallbladder Drainage
Kiyoyuki Kobayashi1,2, Yu Hidaka3, Hideki Kamada4
1Division of Innovative Medicine for Hepatobiliary and Pancreatology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki, Kita, Kagawa, 761-0793, Japan. kobayashi.kiyoyuki@kagawa-u.ac.jp.
Purpose:
Endoscopic gallbladder stenting is an important definitive treatment option for acute cholecystitis in high-risk patients who are poor surgical candidates. In this study, we aimed to compare the outcomes between a novel 5-Fr spiral-shaped plastic stent (IYO-stent) and conventional 7-Fr double-pigtail stent (C-stent) for permanent transpapillary gallbladder drainage.
Methods:
This retrospective cohort study included 56 patients with acute cholecystitis who underwent permanent endoscopic gallbladder stenting at 2 Japanese centers between 2019 and 2023 (C-stent, n = 27; IYO-stent, n = 29). The primary endpoint was event-free survival (EFS), defined as the time to recurrent cholecystitis, procedure-related complications, stent dysfunction, complications requiring intervention, or death. The secondary endpoints were cholecystitis recurrence-free survival and technical success.
Results:
The median EFS was 10.6 months (95% confidence interval [CI], 2.7- not available) in the C-stent group and was not reached in the IYO-stent group; the 24-month EFS rates were 41.6% (95% CI, 22.2-59.9) and 92.0% (95% CI: 71.1-98.0), respectively. The IYO-stent was associated with a lower risk of events compared to the C-stent (adjusted hazard ratio 0.17, 95% CI 0.05-0.55). Cholecystitis recurrence-free survival rates at 24 months were 58.2% with C-stents and 100% with IYO-stents. The technical success was 100% in both groups.
Conclusions:
In high-risk patients undergoing permanent endoscopic transpapillary gallbladder drainage, the novel 5-Fr IYO-stent showed superior long-term efficacy over conventional 7-Fr double-pigtail stents, with markedly improved event-free survival and absence of cholecystitis recurrence during follow-up.
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