Gastrointestinal endoscopy 2018 03 29() pii S0016-5107(18)30250-5
BACKGROUND AND AIMS
ERCP-guided biliary drainage (ERCP-BD is a criterion standard treatment for malignant biliary obstruction when curative surgery is not an option. Alternative methods such as PTBD would significantly lower the quality of life. EUS-guided biliary drainage (EUS-BD) has been developed and performed by experienced endoscopists. Therefore, the aims of this study were to evaluate the efficacy and safety of EUS-BD compared with ERCP in malignant biliary obstruction.
The prospective randomized controlled study was conducted and 30 patients were enrolled; 15 for each EUS-BD and ERCP-BD arm. The technical success, procedural time, clinical success, and adverse events were evaluated.
Thirty patients had extrahepatic malignant biliary tract obstruction (19 males, 11 females). Twenty-seven patients had unresectable PDACs, 1 patient had distal common bile duct (CBD) cancer, and 2 patients had metastatic malignant lymphadenopathy. There were no significant differences both in terms of technical success rate and clinical success rate; 100% versus 93% and 93% versus 100% in ERCP-BD versus EUS-BD, respectively (p=1.00, p=1.00). Four patients (31%) had tumor ingrowth-caused stent dysfunction in the ERCP-BD group, whereas 2 patients had food impaction and 2 patients had stent migration in the EUS-BD group. No significant procedure-related adverse events occurred in either group.
This prospective randomized controlled study suggests that EUS-BD has similar safety to ERCP-BD. EUS-BD was not superior to ERCP-BD in terms of relief of malignant biliary obstruction. EUS-BD may have fewer cases of tumor ingrowth but may also have more cases of food impaction or stent migration. (ClinicalTrials.gov number, NCT01421836.).