Side‐by‐side placement of fully covered metal stents vs. conventional 7F plastic stents in malignant hilar biliary obstruction: A prospective randomized controlled trial
Woo Hyun Paik, Min Kyu Jung, Dong Uk Kim, Tae Jun Song, Min Jae Yang, Young Hoon Choi, Joo Seong Kim, Min Woo Lee, Jin Ho Choi, Sang Hyub Lee - Gastroenterology
- Radiology, Nuclear Medicine and imaging
Objectives
We aimed to evaluate the efficacy and safety of metal stents compared to plastic stents when bilateral side‐by‐side stents were deployed for malignant hilar biliary obstruction (MHBO).
Methods
Fifty patients with unresectable advanced MHBO were randomly assigned to the metal stent (MS, n = 25) or plastic stent group (PS, n = 25). Full‐covered self‐expandable metal stents with 6 mm diameter and plastic stents with either 7F straight or double‐pigtailed were used for MS and PS groups, respectively. Time to recurrent biliary obstruction (TRBO) was evaluated as the primary outcome.
Results
Both groups have 100% of the technical success rates, and the 88% and 76% of clinical success rates were obtained in MS and PS, respectively. Although stent migrations were more frequent in MS than PS (48% vs. 16%, p = 0.02), the mean TRBO was significantly longer in MS (190 [95% CI 121–260] vs. 96 [95% CI 50–141] days, p = 0.02). The placement of plastic stents (HR 2.42 [95% CI 1.24–4.73], p = 0.01) was the only significant risk factor associated with TRBO in multivariable analysis. The rates of adverse events were similar between the two groups (difference 0% [95% CI ‐25% to 25%], p > 0.99).
Conclusions
During bilateral side‐by‐side deployment in MHBO, the use of metal stents appears to be preferable to plastic stents in terms of TRBO, despite a higher frequency of stent migration (