Evaluation of a 12-mm diameter covered self-expandable end bare metal stent for malignant biliary obstruction

Abstract

Background and study aims Biliary metallic stents are used to drain unresectable malignant distal biliary obstructions. This study aimed to evaluate the efficacy of a novel 12-mm-diameter covered, self-expandable end bare metal stent (12-mm CSEEMS). Patients and methods We evaluated 99 patients with unresectable malignant distal biliary obstructions treated with covered biliary metallic stents. Of the 99 patients, 33 underwent 12-mm CSEEMS placement between June 2015 and April 2017 (12-mm-CSEEMS group) and 66 underwent 10-mm fully-covered self-expandable metal stent (FCSEMS) placement between January 2010 and July 2015 (10-mm-FCSEMS group). The overall survival (OS), the recurrent biliary obstruction (RBO), cause of RBO, time to RBO (TRBO) and adverse events in 12-mm-CSEEMS group and 10-mm-FCSEMS group were evaluated retrospectively. Results The OS tended to be longer in the 12-mm-CSEEMS group (log rank, P = 0.081) and TRBO was significantly longer in the 12-mm-CSEEMS group (log rank, P = 0.001) than in the 10-mm-FCSEMS group. Both univariate (HR, 0.449; 95 % CI, 0.27967 – 0.72215; P = 0.001) and multivariate (HR, 0.458; 95 % CI, 0.28395 – 0.73744; P = 0.001) Cox hazard analysis found that risk of RBO was significantly lower in 12-mm CSEEMS than in 10-mm FCSEMS. There were no significant differences between the 12-mm-CSEEMS group and 10-mm-FCSEMS group regarding the cause of RBO and adverse events. Conclusions The 12-mm CSEEMS showed a low risk of RBO compared with 10-mm FCSEMS and was considered to be effective and safe for draining unresectable malignant distal biliary obstruction.

Safety and Efficacy of a Large-Bore Biliary Metallic Stent for Malignant Biliary Obstruction

“…Stent occlusion occurred as a result of sludge formation and tumor in growth in two (5%) patients. In a study of the efficacy of a 12-mm-diameter CSEEMS used in 99 patients with malignant distal biliary obstruction to prevent RBO, the median TRBO was significantly longer than in patients treated using a 10-mm FCSEMS (232 vs. 139.5 days; log-rank test, p = 0.001) [ 21 ]. The occlusion rate was significantly lower in the 10-mm CSEEMS group than in the 10-mm FCSEMS group (9.1% vs. 33.3%; p = 0.009).…”

“…However, although it was a comparative study, a 12-mm CSEEMS is a large-bore partially covered stent, whereas a 10-mm FCSEMS is a conventional fully covered stent. Additionally, the longer time to RBO in the 12-mm CSEEMS group may have been associated with the use of a new type of chemotherapy [ 21 ]. In this study, the incidence of stent occlusion did not significantly differ between the two groups.…”

“…Uncovered SEMSs (UCSEMSs) with a body diameter of 14 mm body can be used to safely and effectively treat malignant biliary obstruction [ 20 ]. Also, the use of a 12-mm covered self-expandable end bare metal stent (CSEEMS) was associated with a lower risk of recurrent biliary obstruction (RBO) than a 10-mm FCSEMS in patients with unresectable malignant biliary obstruction [ 21 ].…”

Current Status of Endoscopic Biliary Drainage in Patients with Distal Malignant Biliary Obstruction

“…The merit of the covered self-expandable metal stent is that it prevents tumor ingrowth and is easy to remove, while the uncovered self-expandable metal stent is thought to prevent stent migration and acute pancreatitis due to self-expandable metal stent compression [ 41 , 42 , 43 , 44 ]. Although there are some reports that a 12 mm self-expandable metal stent is useful for patients with unresectable distal malignant biliary obstruction [ 45 , 46 ], an 8–10 mm diameter of the self-expandable metal stent is generally used ( Figure 3 ). As the self-expandable metal stent has a larger diameter than the plastic stent, endoscopic sphincterotomy is performed as necessary to prevent acute pancreatitis due to self-expandable metal stent compression.…”

Design and evaluation of a novel anti-reflux biliary stent with cone spiral valve

“…Endoscopic placement of a biliary stent is a well-established palliative treatment for biliary obstruction. 1–5 However, the sphincter of Oddi would lose its protective function after stent placement across it. 6 Then duodenum contents will reflux into common bile duct due to the increased duodenal pressure, that is, duodenobiliary reflux, which will result in many complications, such as biliary retrograde infection and cholangitis.…”