PDF icon Download PDF
Open Access
CC BY 4.0 · Journal of Digestive Endoscopy
DOI: 10.1055/s-0045-1811647
Editorial

Primary Endoscopic Ultrasound-Guided Choledochoduodenostomy for Malignant Biliary Obstruction: Are We Becoming Safer and Smarter?

Gaurav Muktesh
1   Department of Gastroenterology, Al Zahra Hospital, Dubai, United Arab Emirates
,
Konstantinos Kossenas
2   Department of Surgery, Laiko General Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece
,
Filippos Georgopoulos
1   Department of Gastroenterology, Al Zahra Hospital, Dubai, United Arab Emirates
› Author Affiliations
› Further Information
Also available ateRef
 
 PDF Download Permissions and Reprints

Endoscopic retrograde cholangiopancreaticography (ERCP) has been the standard of care and the first-line therapy for managing patients with malignant distal biliary obstruction.

However, limitations such as anatomical factors including inability to access the ampulla and risks of post-ERCP pancreatitis and tumor infiltration have led to adoption of endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) procedures at expert centers.

Despite being described for over two decades, widespread adoption of EUS-BD procedures has not taken place.[1] [2]

The major factor limiting the widespread adoption of EUS-BD procedures is the higher rates of complication including bleeding, infection, perforation, stent mal-deployment/migration, and peritonitis, which can sometimes even be fatal.[3]

EUS-guided choledochoduodenostomy (EUS-CDS) is a form of EUS-BD procedure, which establishes direct extrahepatic bile duct–duodenal access. EUS-CDS is increasingly recognized as a viable primary drainage option in expert centers.[4] [5] [6] Compared with ERCP, EUS-CDS offers a shorter procedural time, avoidance of post-ERCP pancreatitis risk, and potentially higher stent patency.

There are lacunae in the available literature regarding predictors of early adverse events (AEs) and how the risks of this extremely useful procedure can be mitigated. Procedure safety can be influenced by several factors beyond operator expertise, such as choosing ideal candidates for the procedure, technical and device modifications, choice of echoendoscopes, etc. We need evidence on methods to improve procedural safety and clinical success rates.

One of the key factors to be able to improve our success rates and decrease the AEs is to have studies having clear inclusion criteria (for instance only including primary EUS-CDS cases as in the study by Okuno et al) and avoid heterogeneity in data. Okuno et al in their study address this vital issue by offering a rare, high-volume, single-center dataset with identification of factors that increased the safety of the primary EUS-CDS procedure.[7]

This was a single-center retrospective study from a high-volume Japanese center which reviewed 306 consecutive EUS-CDS attempts over 22 years (2003–2025), and included 190 cases where the procedure was performed as the initial drainage method in technically ERCP-feasible patients (primary EUS-CDS).[7] Cases performed after failed ERCP and those unsuitable due to factors such as massive ascites or tumor infiltration of the duodenal bulb were excluded (26 patients).

Okuno et al evolved their technique for EUS-CDS over the past two decades and with experience learnt valuable lessons, which they identify in this relevant study.[7]

In the initial period from 2003 to 2011, they were using oblique viewing (OV) echoendoscopes and used a needle knife as a dilator followed by a mechanical dilator (Soehendra dilator) prior to self-expandable metallic stent (SEMS) placement. They evolved to using a coaxial diathermy dilator to dilate the tract prior to stent placement from 2011 onwards. They used both an OV echoendoscope and a front viewing (FV) echoendoscope from 2011 to 2013 and exclusively FV echoendoscopes from 2013 onwards. After 2020, no dilatation of the fistula tract was done prior to stent placement.

One of the key findings of the study in the context of this transition in procedural technique that the authors adopted was sequential decrease in the rate of adverse effects. The rate of early adverse effects was significantly higher in the group treated with a needle knife and a mechanical dilator (18.8%) than in the coaxial electric cautery group (4.7%, p = 0.042) and the group without tract dilation (1.8%, p = 0.008). It is believed that authors learnt over the course of time that increasing the diameter of dilatation with uncontrolled devices increases the risk of bile leak, peritonitis, and bleeding. More importantly, authors have conveyed a powerful and highly useful message that a 6-mm SEMS (using up to a maximum of 7Fr delivery catheter) can be placed successfully even without dilating the fistula tract safely, which is not a practice across many centers around the world. In fact, we in our own practice utilize a 6 Fr coaxial electric cautery catheter prior to placing biliary SEMS during an EUS-CDS procedure, a technique which has stood the test of time. Is it time to change? We will learn as evidence grows.

They also found an OV echoendoscope to be a predictor of early AEs in both univariate (odds ratio [OR]: 4.392, 95% confidence interval [CI]: 1.03–18.64, p = 0.030) and multivariate analyses (OR: 5.153, 95% CI: 1.15–22.92, p = 0.031). It is hypothesized that OV echoendoscopes may increase the risk of double mucosal puncture (which happened in one of the patients in their study) and the same finding has been noted by other authors in the past as well.[8] Even after accounting for the dilation method, endoscope choice remained a significant predictor of AEs in their study. This is an important lesson to be learnt by the endosonologists going forward. Majority of the centers use an OV echoendoscope (including ours) and FV echoendoscope use is restricted to very few centers (that too for limited indications). FV echoendoscopes apart from preventing double mucosal puncture may also help align the guidewire and the SEMS in a linear access, which may assist in easier stent deployment. We feel it may come at the cost of not having an elevator to control the movement of guidewire during instrument exchanges. However, the authors felt they faced no such real-life difficulty and the benefits far outweighed the disadvantages. Moreover, they did not experience any case of stent maldeployment over their two decades of experience.

Okuno and colleagues also reported very high technical (97%) and clinical success rates (97.5%), which exceed previously described success rates in various trials.[5] [6] [9] [10] The early AE rate of 4.9% was also notably lower than the 10 to 15% range seen in earlier primary EUS-CDS series.[5] [6] [9] [10] Such high success rates and very low AEs and not a single case of fatality indicate not just ever-evolving procedural modifications and endoscope choices but also stringent exclusion criteria, where patients with massive ascites and duodenal bulb infiltration were excluded. Endosonologists need to learn that a patient's with massive ascites and bulb infiltration may not be an ideal candidate for EUS-CDS procedure. And also, in certain carefully selected cases, technical and clinical success rates of primary EUS-CDS may exceed that of a routine ERCP for distal primary obstruction, as has been shown previously.

The study by Okuno and colleagues is single center and retrospective in design and hence it has its inherent limitations. We need multicentric prospective trials to confirm the findings of this study. Moreover, since this is a study that pans over two decades, it is possible that early learning curve and temporal trends influenced the poorer outcomes seen with older dilatation methods and endoscope choices. Also, since the rates of AEs were few, they may not have achieved statistically significant difference.

Okuno et al's study provides robust evidence that, in expert hands, primary EUS-CDS can achieve outstanding technical and clinical outcomes with low complication rates. Identification of modifiable procedural factors—scope type and dilation method—offers a clear path to enhance safety. By integrating FV scopes and minimizing dilation into standard protocols, centers may replicate these results and accelerate broader adoption of primary EUS-CDS for malignant distal biliary obstruction, if confirmed by other multicenter prospective studies.

With ever-evolving techniques improving the safety and efficacy for primary EUS-CDS, possibly higher than a routine ERCP, are we getting smarter and safer, I would say surely a yes.


 

Conflict of Interest

None declared.


Address for correspondence

Gaurav Muktesh, MD, DM
Department of Gastroenterology, Alzahra Hospital Dubai
Dubai
United Arab Emirates   

Publication History

Article published online:
16 September 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India


  Permissions and Reprints