Comparison of 8‐ and 10‐mm diameter fully covered self‐expandable metal stents: A multicenter prospective study in patients with distal malignant biliary obstruction

Abstract

Objectives The time to recurrent biliary obstruction (TRBO) of unresectable distal malignant biliary obstruction is generally thought to be longer when a self‐expandable metal stent (SEMS) with a thicker inner diameter is used for drainage, but the dependence on the inner diameter using a fully covered SEMS (FCSEMS) is uncertain. The objective of this multicenter prospective study was to compare TRBO and adverse events, such as cholecystitis and pancreatitis, in treatment of patients with unresectable malignant biliary obstruction using 8‐ and 10‐mm diameter FCSEMS. Methods Eighteen tertiary‐care centers participated in the study. Patients were allocated to the 8‐ and 10‐mm diameter groups. TRBO, non‐inferiority of the 8‐mm FCSEMS, overall survival time, frequency and type of adverse events, and non‐recurrent biliary obstruction (RBO) rate at the time of death were compared between the two groups. Results Median TRBO did not differ significantly between the 8‐mm (n = 102) and 10‐mm (n = 100) groups (275 vs 293 days, P = 0.971). The hazard ratio of the 8‐ to 10‐mm groups was 0.90 (80% confidence interval, 0.77–1.04; upper limit lower than the acceptable hazard ratio [1.33] of the null hypothesis). Based on these findings, the 8‐mm diameter stent was determined to be non‐inferior to the 10‐mm diameter stent. Survival time, incidence of adverse events and non‐RBO rate at the time of death did not differ significantly between the two groups. Conclusions Time to RBO with an 8‐mm diameter FCSEMS was non‐inferior to that with a 10‐mm diameter FCSEMS. This finding is important for development of future SEMS.

SEMS and Sensibility: Self-Expandable Metal Stents for Malignant Biliary Obstruction—Are Stent Characteristics Important?

“…The occurrence of cholecystitis was also similar between the two groups. These findings lend support to the initial use of either SEMS size (8 mm or 10 mm) and are in line with data from a recent prospective study that found that 8-mm fully covered SEMSs were noninferior to 10-mm fully covered SEMSs in terms of time to recurrent biliary obstruction [8]. Nonetheless, recently published data have shown that the success rate of endoscopic revisionary stent insertion for SEMS dysfunction in patients with malignant hilar obstruction was higher in the 10-mm stent group than in the 8-mm one (68% vs. 31%, p = 0.044).…”

The Role of Surgical Resection and Liver Transplantation for the Treatment of Intrahepatic Cholangiocarcinoma

“…High volume centers, a multidisciplinary approach, and appropriate patient selection correlate with overall improved outcomes [ 28 , 33 , 34 , 35 , 36 , 37 ]. In addition to R0 resection, lymph node status is among the most important long-term prognostic factors in iCCA [ 33 , 35 , 38 , 39 , 40 , 41 , 42 ]. Additional independent risk factors for survival include serum carcinoembryonic antigen (CEA) and CA 19–9 levels, tumor diameter and number, presence of vascular invasion, and extrahepatic metastases [ 43 , 44 ].…”

Intraductal placement of a fully covered metal stent with a long string for distal malignant biliary obstruction without endoscopic sphincterotomy: Prospective multi‐center feasibility study

“…Additionally, inward migration may also be mitigated since the stent is less susceptible to peristalsis and food residues. Our experience with intraductal placement of a covered SEMS with a long string reported herein showed better results in terms of time to RBO (339 days) than a recent randomized controlled trial of SEMS placement across the papilla (275-293 days), 26 and successful stent removal using the string at reintervention (77%). Furthermore, there were no cases of ascending cholangitis or liver abscesses, which may be due to a reduction in duodenobiliary reflux.…”