TY - JOUR
T1 - Bilateral versus unilateral placement of metal stents for inoperable high-grade malignant hilar biliary strictures
T2 - a multicenter, prospective, randomized study (with video)
AU - Lee, Tae Hoon
AU - Kim, Tae Hyeon
AU - Moon, Jong Ho
AU - Lee, Sang Hyub
AU - Choi, Hyun Jong
AU - Hwangbo, Young
AU - Hyun, Jong Jin
AU - Choi, Jun Ho
AU - Jeong, Seok
AU - Kim, Jong Hyeok
AU - Park, Do Hyun
AU - Han, Joung Ho
AU - Park, Sang Heum
N1 - Publisher Copyright:
© 2017 American Society for Gastrointestinal Endoscopy
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2017/11
Y1 - 2017/11
N2 - Background and Aims The efficacy of palliative biliary drainage by using bilateral or unilateral self-expandable metal stents (SEMSs) for a malignant hilar biliary stricture (MHS) remains controversial. This prospective, randomized, multicenter study investigated whether bilateral drainage by using SEMSs is superior to unilateral drainage in patients with inoperable MHSs. Methods Patients with inoperable high-grade MHSs who underwent palliative endoscopic insertion of bilateral or unilateral SEMSs were enrolled. The main outcome measurements were the rate of primary reintervention for malfunction after successful placement of SEMSs, stent patency, technical and clinical success rates, adverse events, and survival duration. Results A total of 133 pathology-diagnosed patients were randomized to the bilateral group (n = 67) or the unilateral group (n = 66). The primary technical success rates were 95.5% (64/67) and 100% (66/66) in the bilateral and unilateral groups, respectively (P =.244). The clinical success rates were 95.3% (61/64) and 84.9% (56/66), respectively (P =.047). The primary reintervention rates based on the per-protocol analysis were 42.6% (26/61) in the bilateral group and 60.3% (38/63) in the unilateral group (P =.049). The median cumulative stent patency duration was 252 days in the bilateral group and 139 days in the unilateral group. The risk of stent patency failure was significantly higher in the unilateral group (log-rank test; P <.01). In a multivariate Cox proportional hazard model to assess stent patency, bilateral SEMS placement was a favorable factor (adjusted hazard ratio 0.30, 95% confidence interval, 0.172-0.521; P <.001). Survival probability and late adverse events were not different between the 2 groups. Conclusions Unilateral and bilateral drainage strategies by using SEMSs had similar technical success rates, but bilateral drainage resulted in fewer reinterventions and more durable stent patency in patients with inoperable high-grade MHSs. (Clinical trial registration number: NCT02166970.)
AB - Background and Aims The efficacy of palliative biliary drainage by using bilateral or unilateral self-expandable metal stents (SEMSs) for a malignant hilar biliary stricture (MHS) remains controversial. This prospective, randomized, multicenter study investigated whether bilateral drainage by using SEMSs is superior to unilateral drainage in patients with inoperable MHSs. Methods Patients with inoperable high-grade MHSs who underwent palliative endoscopic insertion of bilateral or unilateral SEMSs were enrolled. The main outcome measurements were the rate of primary reintervention for malfunction after successful placement of SEMSs, stent patency, technical and clinical success rates, adverse events, and survival duration. Results A total of 133 pathology-diagnosed patients were randomized to the bilateral group (n = 67) or the unilateral group (n = 66). The primary technical success rates were 95.5% (64/67) and 100% (66/66) in the bilateral and unilateral groups, respectively (P =.244). The clinical success rates were 95.3% (61/64) and 84.9% (56/66), respectively (P =.047). The primary reintervention rates based on the per-protocol analysis were 42.6% (26/61) in the bilateral group and 60.3% (38/63) in the unilateral group (P =.049). The median cumulative stent patency duration was 252 days in the bilateral group and 139 days in the unilateral group. The risk of stent patency failure was significantly higher in the unilateral group (log-rank test; P <.01). In a multivariate Cox proportional hazard model to assess stent patency, bilateral SEMS placement was a favorable factor (adjusted hazard ratio 0.30, 95% confidence interval, 0.172-0.521; P <.001). Survival probability and late adverse events were not different between the 2 groups. Conclusions Unilateral and bilateral drainage strategies by using SEMSs had similar technical success rates, but bilateral drainage resulted in fewer reinterventions and more durable stent patency in patients with inoperable high-grade MHSs. (Clinical trial registration number: NCT02166970.)
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U2 - 10.1016/j.gie.2017.04.037
DO - 10.1016/j.gie.2017.04.037
M3 - Article
C2 - 28479493
AN - SCOPUS:85020743935
VL - 86
SP - 817
EP - 827
JO - Gastrointestinal Endoscopy
JF - Gastrointestinal Endoscopy
SN - 0016-5107
IS - 5
ER -