Endoscopic ultrasound-guided biliary drainage (EUS-BD) and percutaneous transhepatic biliary drainage (PTBD) are equally effective in treating patients with unresectable malignant distal biliary obstruction and inaccessible papilla, researchers report in the July issue of Clinical Gastroenterology and Hepatology. However, EUS-BD produced fewer procedure-related adverse events and unscheduled re-interventions.
PTBD has been the standard of care after failed ERCP in patients with malignant biliary obstruction. EUS-BD has become an effective alternative for these patients, although these strategies have not been compared directly.
Tae Hoon Lee et al therefore performed a multicenter randomized clinical trial to compare the efficacy of 1-step EUS-BD vs PTBD after a primary failed ERCP in patients with unresectable malignant distal biliary obstruction. Their non-inferiority trial included 66 patients treated at 4 medical centers in South Korea.
A total of 94.1% patients in the EUS-BD group and 96.6% patients in PTBD met the primary end point of technical success. Furthermore, functional success was achieved for 87.5% (28 of 32 patients) in the EUS-BD group and 87.1% (27 of 31 patients) in the PTBD group.
However, a larger proportion of patients receiving PTBD (31.2%) had adverse events compared with patients receiving EUS-BDS (8.8%). Eight patients (25%) in the EUS-BD group and 17 patients (54.8%) in the PTBD group underwent at least one re-intervention. The median hospital stay during the follow-up period was 6 days for EUS-BD and 12 days for PTBD.
There was no difference in the health-related quality of life between the groups. The median cumulative stent patency with EUS-BDS was 228 days—similar to that of the PTBD group (220 days). Patient survival was equivalent between groups.
The findings support the use of EUS-guided biliary drainage for palliation of malignant obstruction.
Lee et al state, however, that the advantage of EUS-BD has been compromised by the lack of standardization of the drainage methods used and variation in access routes, dilation methods, and stent types.
In an editorial that accompanies the article, Todd H. Baron and Ian S. Grimm say that it could take at least 10 years before these procedures can be readily and safely performed outside of tertiary centers. Reaching this stage is not simply a matter of proving feasibility and efficacy with additional comparative studies, but on having the right tools for the job—dedicated EUS therapeutic accessories and devices will most likely make these procedures safer and easier to perform.
Baron and Grimm add that dissemination of interventional EUS beyond a few selected medical centers requires greater emphasis on training in real-time multi-modal imaging and advanced skills in guidewire manipulation and stent placement.