Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD (BESTDRAIN)

Radboud University Medical Center

Status: Active, not recruiting

Conditions: Biliary Obstruction; Cholangiocarcinoma; Pancreatic Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05519605

113346

Details and patient eligibility

About

The vast majority of patients with distal biliary, pancreatic head or uncinate process cancer have jaundice caused by distal malignant obstruction (DMO) of the common bile duct. Biliary drainage by Endoscopic Retrograde Cholangiopancreatography (ERCP) with trans-papillary stent placement is the treatment of choice.

ERCP has a failure rate ranging from 12 - 25 percent. Percutaneous transhepatic biliary drainage (PTBD) is the alternative conventional way to drain the biliary tree after ERCP failure, which is related with substantial morbidity (62%) and mortality (17%). Endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is a novel promising drainage modality with reported excellent outcomes in terms of clinical success and complications.

The implementation of EUS-BD besides ERCP and PTBD into Dutch daily clinical practice raises many questions related to performance, costs, QoL, training, implementation and overall oncological treatment success. This structured learning/proctoring program with an additional national registry provides insights into EUS-BD and how to implement EUS-BD in the Dutch standard of care.

Full description

The study is designed as a prospective multicenter registry. The data obtained in this study will enable the EUS-BD procedure to progress to larger multicenter and preferably randomized control trials.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and older
• Distal malignant CBD obstruction (from ampulla to 1cm distal to the hilum)
• Indication for biliary drainage after failed ERCP-guided biliary drainage

Exclusion criteria

• Previous PTBD and/or EUS-BD
• Inability to provide informed consent
• Pregnancy
• American Society of Anesthesiology (ASA) Grade IV-V

Trial design

61 participants in 2 patient groups

PTBD after failed ERCP

Description:

Patients with a distal malignant obstruction undergoing placement of a percutaneous transhepatic biliary drain after failed ERCP.

EUS-BD after failed ERCP

Description:

Patients with a distal malignant obstruction undergoing EUS-guided biliary drainage after failed ERCP.