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

Pancreatic Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05519605
Study type Observational [Patient Registry]
Source Radboud University Medical Center
Contact
Status Active, not recruiting
Phase
Start date August 1, 2022
Completion date July 1, 2024
View Details
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