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

NCT ID: NCT05519605

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2024-07-01

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.

Conditions

Pancreatic Cancer; Cholangiocarcinoma; Biliary Obstruction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PTBD after failed ERCP

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

No interventions assigned to this group

EUS-BD after failed ERCP

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboudumc

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

113346

Identifier Type: -

Identifier Source: org_study_id