Journal Watch EUS-guided biliary drainage as first-line therapy in patients with Malignant Distal Biliary Obstruction

MEMBER ARTICLE

EUS-Guided Biliary Drainage of First Intent with a Lumen-Apposing Metal Stent vs ERCP for Malignant Distal Biliary Obstruction

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EUS-Guided Biliary Drainage of First Intent with a Lumen-Apposing Metal Stent vs ERCP for Malignant Distal Biliary Obstruction

 Chen YI, Sahai A, Donatelli G, Lam E, Forbes N, Mosko J, et al. Gastroenterology. 2023 Aug 6; S0016-5085(23)04877-1. doi: 10.1053/j.gastro.2023.07.024. Online ahead of print.

Question

Endoscopic ultrasound–guided choledochoduodenostomy (EUS-CDS) as first-line therapy leads to more sustainable adequate biliary drainage than ERCP over 1 year in patients with malignant distal biliary obstruction.

Design 

Multicenter randomized controlled trial, patient and outcome assessor blinded.

Patients

Adult patients with a radiologic diagnosis of borderline resectable, locally advanced, or unresectable malignant distal (>2cm from hilum) biliary obstruction.

Interventions

Patients were randomly allocated to one of the two approaches in a 1:1 ratio using a block size of 4. Allocation was stratified by site and tumor stage (stage 3 vs. stage 4). Patients deemed resectable were excluded from the study. Crossovers to the other modality were allowed in cases of technical failure. A medical effectiveness approach was adopted - i.e., the trial protocol only dictated initial randomized allocation and not the subsequent management decisions (in cases of technical failure, crossover to the other treatment group was not mandated, and different approaches, including a repeat ERCP attempt or percutaneous drainage, could be chosen as per the endoscopist and treating team).

Outcome

The primary outcome was the rate of stent dysfunction (due to migration or stent blockage) requiring re-intervention as defined by the following criteria: endoscopic or radiologic re-intervention confirming stent blockage or migration needing stent cleaning, stent change, and/or additional stent insertion, and at least one of the following: 1) suspected or definite cholangitis (Tokyo consensus definition), 2) ≥50% increase in bilirubin from the lowest level post index procedure, 3) ≥20% increase in bilirubin from the lowest level post index procedure as well as evidence of obstruction on imaging.

Additional outcomes included technical success, initial clinical success, and adverse events. Data were collected at the index procedure and on days 14, 30, 90, 180, 270, and 365. Patients were followed until death or a total of 1-year follow-up.

Data analysis

Analyses were performed according to intention-to-treat (ITT) principles. Kaplan-Meier curves and Fine and Gray proportional hazards models were used to compare the primary endpoint (stent dysfunction) between the EUS-CDS and ERCP-M stratifying by center and tumor stage and accounting for competing risks (initial stent clinical failure, mortality, and surgery). Stent patency was estimated from the primary survival analyses.

Funding

Canadian Institute of Health Research (CIHR) project grant, Fonds de Recherche Sante Quebec (FRQS) career grant, American Society for Gastrointestinal Endoscopy (ASGE) Research Award, at arms funding from Boston Scientific Inc.

 Results 

From February 2019 to February 2022, 144 patients were randomized, with 73 patients allocated to EUS-CDS and 71 to ERCP-M. The two techniques were comparable regarding technical success (90.4% (CI95%:81.5-95.3) of EUS-CDS and 83.1% (CI95%:72.7-90.1) of ERCP-M), initial clinical success (84.9% (CI95%:76.5-93.3) of EUS-CDS and 85.9% (CI95%:77.6-94.2) of ERCP-M), and procedure-related adverse events (12.3% (CI95%:6.6- 21.8) of EUS-CDS and 12.7% (CI95%:6.8-22.4) of ERCP-M. The rate of stent dysfunction was also comparable between the groups (9.8% with EUS-CDS vs. 8.8% with ERCP-M; P = .55).

COMMENTARY

Why Is This Important?

EUS-BD has proven to be a helpful alternative in patients with malignant distal bile duct obstruction and failed ERCP. Previous studies suggest that EUS-BD can be equivalent to ERCP as the first option for biliary drainage in patients with malignant distal obstruction [1-3], with the advantage of providing a precise image and tissue for diagnosis, besides the palliative therapy in one session using only one endoscope. In these studies, the primary outcomes were different than the current one: in the study of Bang JY et al. (1), the primary endpoint was the rate of adverse events,  Paik WH et al. (2) had as the primary outcome the technical success rate, and in Kawakubo K et al. (3), the aim was to compare the clinical efficacy and safety.

Given that LAMS does not traverse the tumor, one would assume that the EUS-based approach would be associated with superior stent patency. The present study has that question as the primary outcome. Unfortunately, no such advantage was observed in this study.

Key Study Findings

EUS-CDS using a lumen-apposing metal stent is not superior to ERCP with self-expanding metal stent insertion in reducing stent dysfunction in managing malignant distal biliary obstruction.

Nevertheless, it is an efficient, effective, and safe first-line alternative to ERCP-M with comparable technical success. EUS-CDS is associated with a shorter procedure time.

Caution

The advantage of the EUS over the ERCP regarding the time could be underrated in the present study mainly because, according to the methods, some of the operators in the present study have low EUS-CDS experience.

One interesting point was the number of fatal/severe complications in the ERCP group. The authors divided the adverse events as early and late (≤ 14 days and > 14 days from index procedure), and no statistical differences were detected. However, when considered as a total, the number of fatal/severe adverse events in the ERCP-M group is almost three times that in the EUS-CDS group (8 [11.2%] vs. 3 [4.1%]).

My Practice

I have done both procedures for over 10 years and feel comfortable doing both. I continue with ERCP as the first-line option, but my threshold for switching to EUS biliary drainage is lower and lower. In practice, EUS-BD is faster and often more accessible than the ERCP. 

Shortly, the recommendation could be that ERCP and EUS-GBD are equivalents as first-line therapy for patients with malignant distal biliary obstruction.

For Future Research

One crucial aspect is the costs of each modality. The shorter procedure time, the same session tissue diagnosis, and the need for fluoroscopy are variables that could change the balance.

 

REFERENCES 

1.- Bang JY, Navaneethan U, Hasan M, Hawes R, Varadarajulu S. Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos). Gastrointest Endosc 2018; 88:9–17

2. Paik WH, Lee TH, Park DH, Choi JH, Kim SO, Jang S, Kim DU, Shim JH, Song TJ, Lee SS, Seo DW, Lee SK, Kim MH. EUS-guided biliary drainage versus ERCP for the primary palliation of malignant biliary obstruction: a multicenter randomized clinical trial. Am J Gastroenterol 2018; 113:987–997.

3. Kawakubo K, Kawakami H, Kuwatani M, Kubota Y, Kawahata S, Kubo K, Sakamoto N. Endoscopic ultrasound-guided choledochoduodenostomy vs. transpapillary stenting for distal biliary obstruction. Endoscopy 2016; 48:164–169.

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