Bile Duct Drainage After ERCP Failure: EUS-guided Biliary Versus Percutaneous Transhepatic Drainage
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- Radboud University Medical Center
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Complications of PTBD vs EUS-BD
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Complications of PTBD vs EUS-BD
Time Frame: 180 days
The primary outcome measure is a composite of severe complications occurring within 180 days following inclusion, analyzed by intention to treat. Complications we score are: bleeding, perforation, biliary leak, biliary peritonitis, abscess, haemobilia, stent occlusion, cholangitis, pancreatitis, anesthesia related complications, severe post-procedural pain, drain/stent dysfunction, cutaneous fistula, stent migration and drain leakage or dislocation.
Secondary Outcomes
- Stent/drain patency(180 days)
- Technical success of the initial procedure(180 days)
- Clinical success(180 days)
- Treatment delay(180 days)
- Effect of EUS-BD and PTBD on the difficulty of surgery.(180 days)
- Length of hospital stay(180 days)
- Time to re-intervention and number of re-interventions(180 days)
- Successful training(180 days)