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

NCT05519605 | Unknown

• 1 other identifier: 113346
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Cholangiocarcinoma; Biliary Obstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Technical success of the initial procedure

  180 days

• Clinical success

  180 days

• Length of hospital stay

  180 days

• Stent/drain patency

  180 days

• Treatment delay

  180 days

Study Arms (2)

PTBD after failed ERCP

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

EUS-BD after failed ERCP

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• Previous PTBD and/or EUS-BD
• Inability to provide informed consent
• Pregnancy
• American Society of Anesthesiology (ASA) Grade IV-V

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 180 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 29, 2022
• Study Start: August 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 11, 2024

Record last verified: 2023-12

Locations

NL (1)