Is Upfront EUS-Guided Biliary Drainage a Wise Option in Patients With Malignant Distal Biliary Obstruction?

Is Upfront EUS-Guided Biliary Drainage a Wise Option in Patients With Malignant Distal Biliary Obstruction?

Vanessa M. Shami, MD, FASGE, reviewing Chen YI, et al. Gastroenterology 2023 Aug 5.

Traditionally, malignant biliary obstruction is relieved by placing a transpapillary stent during endoscopic retrograde cholangioscopy (ERCP). Pancreatitis is a possible adverse event of ERCP. Additionally, stent obstruction is increasingly observed in patients because of improved survival, necessitating another procedure. Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent is an option in patients with malignant distal biliary obstruction (MDBO). This approach avoids pancreatitis and possibly the need for a repeat procedure. This procedure usually is reserved for patients for whom ERCP has been unsuccessful. This multicenter, randomized controlled trial compared outcomes of upfront EUS-CDS with those of ERCP with metal stenting (ERCP-M) in patients with MDBO. 

From February 2019 to February 2022, 144 patients from 11 institutions were randomized to EUS-CDS or ERCP-M (n=73 vs 71, respectively). All patients had borderline resectable, locally advanced, or unresectable disease. This was a noninferiority assessment of technical success. The primary outcome was the rate of stent dysfunction caused by migration or stent blockage that required reintervention at one year. Secondary outcomes included technical success, initial clinical success, and adverse events. The investigators performed intention-to-treat analyses. 

There was no difference in stent dysfunction between groups (9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively [P=.96]). Technical success was achieved in 90.4% (95% confidence interval [CI], 81.5%-95.3%) of EUS-CDS procedures and 83.1% (95% CI, 72.7%-90.1%) of ERCP-M, with a risk difference of 7.3% (95% CI, -4.0% to 18.8%), indicating noninferiority. The mean procedure time was 14.0 ± 11.4 minutes with EUS-CDS versus 23.1 ± 15.6 minutes with ERCP-M (P<.01). Fluoroscopy was not used in 40% of the EUS-CDS procedures. There were no differences in adverse events, pancreaticoduodenectomy, oncological outcomes, or quality of life.

Vanessa M. Shami, MD, FASGE


Although EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO, the endoscopists who performed these procedures are experts in EUS-guided interventions. Technical naivety may limit the EUS approach in many centers, and this technique will most likely continue to be performed in patients for whom ERCP is unsuccessful.


Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.


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 Aug 5. (Epub ahead of print) (

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