Usefulness of a laser-cut covered metal stent with a 7F delivery sheath in endoscopic ultrasound-guided biliary drainage without fistula dilation

Abstract

Background and study aims Recently, the utility of endoscopic ultrasound-guided intervention without fistula dilation (EUS-IV WoD) has been reported to prevent adverse events. We clinically evaluated cases in which EUS-IV WoD was attempted using a novel self-expandable metallic stent (SEMS); this is a fully covered, laser-cut SEMS that has a tapered and stiff tip specifically designed for a 0.025-inch guidewire and a relatively thin, 7F delivery system. Patients and methods We retrospectively evaluated cases wherein EUS-IV WoD was attempted using the novel SEMS between March and December 2021. Results Treatment of 11 patients by EUS-IV WoD with the novel SEMS was attempted. The technical success rate for EUS-IV was 100 % and the clinical success rate was 100 %; the success rate for EUS-IV WoD was 72.8 %. Of these, the procedural success rate for EUS-IV WoD was 100 % in EUS-biliary drainage (BD) and 57.1 % in non-EUS-BD. Early adverse events were observed in 27.3 % of patients (3/11): mild abdominal pain in two patients and moderate bleeding in one patient. The abdominal pain cases were both cases of EUS-IV WoD failure and required fistula dilation. Conclusions The novel stent may be useful for EUS-IV WoD, especially in EUS-BD.

Fig. 1 a

A novel stent, the covered BileRush Advance. b, c The stent has a 7F delivery and a stiff tip tapered to a 0.025-inch guidewire. The stent diameter is 8 mm (or 10 mm), with a 10-mm (or 12-mm) flared portion at both ends; the length is 6 cm or 8 cm.

Fig. 2

Flow diagram. Endoscopic ultrasound-guided intervention (EUS-IV) was performed on 86 patients and details of the procedure were noted. The percentages of EUS-IV without fistula dilation procedures attempted with the covered BileRush Advance among all cases of EUS-IV were 9.4 % (3/32) for EUS-guided hepaticogastrostomy, 3.6 % (1/28) for EUS-guided choledochoduodenostomy, 50 % (1/2) for EUS-gallbladder drainage, 100 % (5/5) for EUS-gastroenterostomy, and 7.7 % (1/13) for EUS-cyst drainage. EUS, endoscopic ultrasound; IV, intervention; HGS, hepaticogastrostomy; CDS, choledochoduodenostomy; GBD, gallbladder drainage; GE, gastroenterostomy; CD, cyst drainage; PD, pancreatic duct drainage; WoD, without fistula dilation

Fig. 3

The Kaplan–Meier curve of time to reintervention. a The median observation period of all 11 cases of endoscopic ultrasound-guided intervention (EUS-IV) with the novel self-expandable metallic stents was 71 days (21–427), incidence of stent dysfunction was 9.1 % (1/11), and median time to stent dysfunction was not reached (95 % CI; 110-NA). b The median observation period for the four patients who underwent EUS-guided biliary drainage was 118 days (40–427), with an incidence of recurrent biliary obstruction of 0 % (0/4). c The median observation period for the five patients who underwent EUS-guided gastroenterostomy was 62 days (21–176), with an incidence of stent dysfunction of 20 % (1/5). The median time to stent dysfunction was 110 days (95 % CI; 110-NA). EUS, endoscopic ultrasound; IV, intervention; BD, biliary drainage; GE, gastroenterostomy.

Fig. 4

Reintervention was performed because the placed self-expandable metallic stent for endoscopic ultrasound-guided gastroenterostomy ruptured. a The ruptured stent (yellow arrow) is shown; the anchoring plastic stent maintained the fistula in an afferent-loop.  b The residual stent could not be removed. c, d A guidewire was inserted into the fistula over the residual stent and two half pig-tail plastic stents were placed. Clinical improvement was achieved.

Fig. 5

Whether the target of endoscopic ultrasound-guided intervention (EUS-IV) is intraperitoneally fixed (red arrows) or not (blue arrows) could be the determining factor for the failure of EUS-IV without fistula dilation. a The targets of EUS-HGS, EUS-CDS and EUS-GBD are fixed. b Those of EUS-GE and EUS-CD are unfixed. EUS, endoscopic ultrasound; HGS, hepaticogastrostomy; CDS, choledochoduodenostomy; GBD, gallbladder drainage; GE, gastroenterostomy; CD, cyst drainage.