Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis

Abstract

In endoscopic biliary drainage (EBD) for various benign and malignant biliary disorders, the appropriate timing to replace or change a plastic stent (PS) with a self-expandable metallic stent (SEMS) remains unclear. This study aimed to define the best period to replace or change a PS with a SEMS. Between January 1, 2012, and December 31, 2018, 1,887 consecutive EBD procedures, including 170 SEMS placements, were retrospectively identified. The period to recurrent biliary obstruction (PRBO) was estimated and compared between the malignant and benign groups and according to each disease using time to event analysis and competing risk analysis. Compared with the benign group, the malignant group had significantly shorter median PRBO with interquartile range (IQR) after PS placement [108 (39 – 270) vs. 613 (191 – 1,329) days, P < 0.001], even on multivariate analysis, with a subdistribution hazard ratio (SHR) of 3.58 (P < 0.001). The shortest PRBO distribution from the first quartile of the non-RBO period was seen in Mirizzi syndrome cases (25 days, P = 0.030, SHR = 3.32) in the benign group and in cases of pancreatic cancer (32 days, P = 0.041, SHR = 2.06); perihilar bile duct cancer (27 days, P = 0.006, SHR = 2.69); and ampullary cancer (22 days, P = 0.001, SHR = 3.78) in the malignant group. Our study supports that stent replacement for the benign group is feasible after 6 months, and the best period to replace or change a PS with a SEMS should be decided on the basis of the underlying disease to prevent RBO.

Efficacy and safety of temperature‐controlled intraductal radiofrequency ablation in advanced malignant hilar biliary obstruction: A pilot multicenter randomized comparative trial

“…28,29 However, it is difficult to predict the actual period to stent obstruction. 27 Therefore, our result that more patients underwent scheduled sequential procedure in 3 months after the index procedure without PS occlusion is notable. It is suggested that ID-RFA is beneficial by preventing premature stent occlusion before scheduled exchange.…”

“…To avoid this, guidelines state scheduled stent exchange could be a strategy for better outcomes 28,29 . However, it is difficult to predict the actual period to stent obstruction 27 . Therefore, our result that more patients underwent scheduled sequential procedure in 3 months after the index procedure without PS occlusion is notable.…”

“…After PS placement, recurrent biliary obstruction could worsen the patients' quality of life or bring on a life-threatening condition. 27 To avoid this, guidelines state scheduled stent exchange could be a strategy for better outcomes. 28,29 However, it is difficult to predict the actual period to stent obstruction.…”

Use of self-expandable metallic stents for endoscopic biliary decompression decreases stent complications in pancreatic cancer patients receiving chemotherapy

“…Among 26 NAT patients with a plastic stent dysfunction, 16 (62%) patients received a SEMS during the first repeat ERCP. The decision on changing the stent type from plastic stent to SEMS was made based on guidelines and studies supporting the replacement of plastic stents to SEMSs on the basis of the underlying disease [ 6 , 17 ]. Median time from primary biliary drainage to first repeat ERCP among NAT patients with plastic stents was 77 days (range 9–263 days).…”

Potential significance of uncovered self‐expandable metal stents for distal malignant biliary obstruction: A propensity score‐adjusted competing risk regression analysis

“…Patient death was treated as a censor, and differences were evaluated using the log‐rank test for the Kaplan–Meier analysis (Figure 2a). The Fine and Gray model, based on a subdistribution hazard (SHR) model, was used for the competing‐risks regression (CRR) 4,26,28 . To include death in this model's informative censoring for potential RBO, death without RBO was treated as a competing risk.…”