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

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

NCT ID: NCT05519605

Condition: Pancreatic Cancer
Cholangiocarcinoma
Biliary Obstruction

Conditions: Official terms:
Cholangiocarcinoma

Study type: Observational [Patient Registry]

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

Study pop:
Patients aged 18 years or older with a distal malignant obstruction of the common bile duct with failure of drainage by the initial ERCP will be included in this study. Failed biliary drainage is defined as failed common bile duct cannulation during ERCP by an experienced advanced endoscopist (>100 ERCP/year, case load > 500 ERCP).

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Radboudumc

Address:
City: Nijmegen
Zip: 6525GA
Country: Netherlands

Start date: August 1, 2022

Completion date: July 1, 2024

Lead sponsor:
Agency: Radboud University Medical Center
Agency class: Other

Source: Radboud University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05519605