1. Bilateral versus unilateral placement of metal stents for inoperable high-grade malignant hilar biliary strictures: a multicenter, prospective, randomized study (with video)
- Author
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Tae Hoon Lee, Hyun Jong Choi, Sang Hyub Lee, Jong Ho Moon, Jong Jin Hyun, Jong Hyeok Kim, Sang Heum Park, Young Hwangbo, Seok Jeong, Jun-Ho Choi, Joung-Ho Han, Tae Hyeon Kim, and Do Hyun Park
- Subjects
medicine.medical_specialty ,Magnetic resonance cholangiopancreatography ,Biliary drainage ,Intention-to-treat analysis ,Endoscopic retrograde cholangiopancreatography ,medicine.diagnostic_test ,business.industry ,Gastroenterology ,Magnetic resonance imaging ,Surgery ,Clinical trial ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,medicine ,030211 gastroenterology & hepatology ,Radiology, Nuclear Medicine and imaging ,Prospective randomized study ,Radiology ,Adverse effect ,business - Abstract
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 P 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.)
- Published
- 2017