Tae Hoon Lee1, Tae Hyeon Kim2, Jong Ho Moon3, Sang Hyub Lee4, Hyun Jong Choi3, Young Hwangbo5, Jong Jin Hyun6, Jun-Ho Choi7, Seok Jeong8, Jong Hyeok Kim9, Do Hyun Park10, Joung-Ho Han11, Sang-Heum Park1. 1. Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, Republic of Korea. 2. Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Republic of Korea. 3. Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon Hospital, Bucheon, Republic of Korea. 4. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea. 5. Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, Republic of Korea. 6. Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea. 7. Department of Internal Medicine, Dankook University College of Medicine, Cheonan, Republic of Korea. 8. Department of Internal Medicine, Inha University School of Medicine, Incheon, Republic of Korea. 9. Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea. 10. Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea. 11. Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
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 < .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.).
RCT Entities:
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.).