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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bile Duct Drainage After ERCP Failure: EUS-guided Biliary Versus Percutaneous Transhepatic Drainage

Conditions
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Pancreatic Cancer, Cholangiocarcinoma, Biliary Obstruction

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PTBD after failed ERCP<br>Patients with a distal malignant obstruction undergoing placement of a percutaneous transhepatic biliary drain after failed ERCP. | |
| EUS-BD after failed ERCP<br>Patients with a distal malignant obstruction undergoing EUS-guided biliary drainage after failed ERCP. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of PTBD vs EUS-BD | 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. | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success of the initial procedure | Defined as: the ability to access and drain the bile duct by placement of a stent/drain. | 180 days | 
| Clinical success | A post-intervention reduction of bilirubin below 35 umol/L or a significant decline, so that chemotherapy could be administered at the discretion of the oncologist. Serum bilirubin is routinely measured as part of clinical practice after biliary drainage. | 180 days | 
| Length of hospital stay | Split into total admission days, length of initial admission and total duration of subsequent admissions; an out-patient procedure performed at the hospital is counted as one admission day | 180 days | 
| Stent/drain patency | Stent/drain patency is measured by the interval (days) between the time of stent placement and stent/drain malfunction or patient death. | 180 days | 
| Treatment delay | For each severe complication, the treatment team will be asked whether the complication would alter (delay or modify) the pre-existing treatment plan | 180 days | 
| Time to re-intervention and number of re-interventions |  | 180 days | 
| Successful training | Successful training defined as significant progress in learning curve calculated by a CUSUM-analysis | 180 days | 
| Effect of EUS-BD and PTBD on the difficulty of surgery. |  | 180 days |