Endoscopic ultrasound-guided choledochoduodenostomy: is the rate of stent dysfunction underestimated?

In this issue of Endoscopy, Fritzsche et al. from Amsterdam present the results of their prospective study on endoscopic ultrasound-guided choledochoduodenostomy (EUS-CD) for the primary drainage of malignant distal biliary obstruction (MDBO) (SCORPION-p study) [1]. The authors reported very high technical and clinical success rates of 91% and 86%, respectively, which are comparable to those reported in the literature [2]. In a recent multicenter series with EUS-CD performed in patients with endoscopic retrograde cholangiopancreatography (ERCP) failure, the results were the same, with 92% and 86% technical and clinical success rates, respectively [3]. These rates were also confirmed in another systematic review and meta-analysis including lumen-apposing metal stents (LAMS) and self-expandable metal stents (SEMS), with technical and clinical success rates of 94.8% and 93.6%, respectively [4]. Therefore, the efficacy of EUS-CD is about 90% or more in the literature and the discussion should be focused on adverse events or recurrent jaundice, which have been reported to be 5.6% and 11.3%, respectively [5].

In the Fritzsche et al. study, the authors did not report immediate procedural or periprocedural adverse events, showing that in expert centers, EUS-CD could be safe. In contrast, the authors found an unusually high rate of stent dysfunction (55%) when they followed the patients for at least 6 months, this rate being much higher than that reported in the literature (6%–37%). This is probably the feeling of many operators in real life. Thus, we should be mindful of the risk factors for stent dysfunction as well as strategies to prevent stent dysfunction.

“The high rate of stent dysfunction reported in this study should prompt the careful follow-up of patients, limiting the indication of EUS-CD to patients with a common bile duct diameter of >15 mm, and avoiding cases of duodenal invasion.”

The frequency, risk factors, classification, and prevention of stent dysfunction reported in the literature are controversial [2] [6] [7]. The results of 155 studies on EUS-guided biliary drainage found rates of stent migration or occlusion of 1.7% and 11%, respectively [6]. The reintervention rate was 16.2%, which is perhaps more representative of the overall rate of stent dysfunction [6]. Risk factors were assessed in a prospective single-center study in patients undergoing EUS-CD, more than 75% of whom had MDBO [7]. Overall, 16.3% of patients presented biliary obstruction during a mean follow-up of 242 days. The multivariate analysis showed two significant risk factors associated with long-term stent obstruction: a common bile duct (CBD) diameter <15 mm and presence of a duodenal stent [7]. The Leuven–Amsterdam–Milan study also assessed the characteristics, rate, and risk factors for choledochoduodenostomy stent dysfunction [2]. In this study, 93 patients with MDBO were followed, with 6-mm stents implanted in two-thirds of the patients. Stent dysfunction occurred in 31.8% of patients within a mean of 166 days, which is the closest result to the 55% rate identified in the Fritzsche et al. study [1]. Almost all stent dysfunctions were successfully managed endoscopically (96%) [2]. The only predictive risk factor in this study was duodenal invasion, and the dysfunction-free survival was 75% at 6 months and 52% at 12 months [2]. In the Fritzsche et al. study, stent dysfunction occurred in 11/20 patients (55%) within 6 months and the median dysfunction-free survival was 140 days, stent dysfunction clearly occurring earlier in this series. The Fritzsche et al. study is probably more clinically relevant, as the diagnosis of stent dysfunction was a prospective combination of cholangitis and/or cholestasis or jaundice [1]. All the stents used were 6 mm in diameter, which may also be a risk factor for earlier stent dysfunction. It seems that stents with larger diameters could be associated with a decreased rate of reintervention (despite the same technical success) compared with stent diameters of 8 or 10 mm [8].

Strategies aimed at preventing stent dysfunction remain under debate. Many series have reported that previous duodenal stenting or duodenal stenosis is associated with a higher rate of stent dysfunction [2] [7] [9]. The first recommendation should be to avoid any EUS-CD in cases of duodenal invasion. The present study included only MDBO without clinically relevant gastric outlet obstruction but the stent dysfunction rate was high [1]. A prospective study reported that relatively weak dilation of the CBD is a risk factor for complications: for CBD diameters <12mm, EUS-CD should be avoided; between 12–15 mm, EUS-CD should be performed only by an expert; and a CBD diameter >15 mm should be the best indication for a non-expert [10]. Although the Fritzsche et al. study did not report stent misdeployment or dislodgment, such complication is severe, reaching a rate of 5.8% in a recent study [11]. In case of misdeployment, there is no consensus about rescue techniques, but one of the main options could be to use a preloaded guided wire in order to switch to the stent-in-stent technique in cases of misdeployment, limiting further surgical management to a rate of 10.3% [11].

In addition to avoiding risk factors such as gastric outlet obstruction or insufficient dilation of the CBD, some authors have proposed inserting a double-pigtail stent within the LAMS in order to avoid biliary mucosal intussusception or food impaction [12]. A retrospective multicenter study assessing the insertion of a double-pigtail stent throughout the LAMS showed similar results regarding clinical efficacy and adverse events, but the rate of recurrent biliary obstruction yielded favorable results (13.6% vs. 23.5%) [12]. A randomized controlled trial on this topic is currently under way in Spain, the BAMPI study [13].

To conclude, in the context of the current literature on the efficiency and safety of EUS-CD, it is acceptable to propose EUS-CD as the first-line approach for the management of MDBO according to the expertise of the center, but the important risk for stent dysfunction must be considered. In this perspective, two recent randomized series showed noninferior or better results when comparing EUS-CD with ERCP [14] [15]. The high rate of stent dysfunction reported in the Fritzsche et al. study should prompt the careful follow-up of patients, limiting the indication of EUS-CD to patients with a CBD diameter of >15 mm, and avoiding cases of duodenal invasion. Insertion of a double-pigtail stent inside the LAMS should delay any stent dysfunction.

Publication History

Article published online:
14 November 2023

• References

• 1 Fritzsche JA, Fockens P, Besselink MG. et al. Endoscopic ultrasound-guided choledochoduodenostomy using single-step lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-p): a prospective pilot study. Endoscopy 2024; 56 DOI: 10.1055/a-2134-3537.
• 2 Vanella G, Bronswijk M, Dell’Anna G. et al. Classification, risk factors, and management of lumen apposing metal stent dysfunction during follow-up of endoscopic ultrasound-guided choledochoduodenostomy: multicenter evaluation from the Leuven–Amsterdam–Milan Study Group. Dig Endosc 2023; 35: 377-388
• 3 Fugazza A, Fabbri C, Di Mitri R. et al. EUS-guided choledochododenostomy for malignant distal biliary obstruction after failed ERCP: a retrospective nationwide analysis. Gastrointest Endosc 2022; 95: 896-904
• 4 Amato A, Sinagra E, Celsa C. et al. Efficacy of lumen-apposing metal stents or self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy: a systematic review and meta-analysis. Endoscopy 2021; 53: 1037-1047 DOI: 10.1055/a-1324-7919. (PMID: 33246343)
• 5 Krishnamoorthi R, Dasari CS, Chandrasekar VT. et al. Effectiveness and safety of EUS-guided choledochoduodenostomy using lumen-apposing metal stents (LAMS): a systematic review and meta-analysis. Surg Endosc 2020; 34: 2866-2877
• 6 Giri S, Mohan BP, Jearth V. et al. Adverse events with endoscopic-ultrasound guided biliary drainage: a systematic review and meta-analysis. Gastrointest Endosc 2023; 98: 515-523.e18
• 7 Geyl S, Redelsperger B, Yzet C. et al. Risk factors for stent dysfunction during long-term follow-up after EUS-guided biliary drainage using lumen-apposing metal stents: a prospective study. Endosc Ultrasound 2023; 12: 237-244
• 8 On W, ParanandiBSmith AM. et al. EUS-guided choledochoduodenostomy with electrocautery-enhanced lumen-apposing metal stents in patients with malignant distal biliary obstruction: multicenter collaboration from the United Kingdom and Ireland. Gastrointest Endosc 2022; 95: 432-442
• 9 VanellaGBronswijk M, van Wanrooij RLJ. et al. Combined endoscopic management of biliary and gastric outlet obstruction (CABRIOLET Study): a multicenter retrospective analysis. DEN Open 2022; 3: e132
• 10 Rimbas M, Anderloni A, Napoleon B. et al. Common bile-duct size in malignant distal obstruction and lumen-apposing metal stents: a multicenter prospective study. Endosc It Open 2021; E1801-E1810
• 11 Armellini E, Metelli F, Anderloni A. et al. Lumen-apposing metal stent misdeployment in endoscopic ultrasound-guided drainages: a systematic review on issues and rescue management. World J Gastroenterol 2023; 29: 3341-3361 DOI: 10.3748/wjg.v29.i21.3341. (PMID: 37377584)
• 12 Garcia-Sumalla A, Loras C, Guarner-Argente C. et al. Is a coaxial plastic stent within a lumen-apposing metal stent useful for the management of malignant distal biliary obstruction. Surg Endosc 2021; 35: 4873-4881
• 13 Garcia-Sumalla A, Loras C, Sanchiz V. et al. Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction-BAMPI TRIAL: an open-label, randomized controlled trial protocol. Trials 2022; 23: 181. Erratum in Trials 2022; 23: 214 DOI: 10.1186/s13063-022-06106-1. (PMID: 35216619)
• 14 Chen YI, Sahai A, Donatelli G. et al. Endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs endoscopic retrograde cholangiopancreatography in malignant distal biliary obstruction: a multicenter randomized controlled study (ELEMENT trial). Gastroenterology 2023; 165: 1249-1261
• 15 Teoh AYB, Napolelon B, Kunda R. et al. EUS-guided choledocho-duodenostomy using lumen apposing stent versus ERCP with covered metallic stents in patients with unresectable malignant distal biliary obstruction: a multicenter randomized controlled trial (DRA-MBO trial). Gastroenterology 2023; 165: 473-482.e2