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

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ClinicalTrials.gov Identifier: NCT05519605
Recruitment Status : Recruiting
First Posted : August 29, 2022
Last Update Posted : August 29, 2022
Sponsor:
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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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.


Condition or disease
Pancreatic Cancer Cholangiocarcinoma Biliary Obstruction

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 180 Days
Official Title: Bile Duct Drainage After ERCP Failure: EUS-guided Biliary Versus Percutaneous Transhepatic Drainage
Actual Study Start Date : August 1, 2022
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Complications of PTBD vs EUS-BD [ Time Frame: 180 days ]
    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.


Secondary Outcome Measures :
  1. Technical success of the initial procedure [ Time Frame: 180 days ]
    Defined as: the ability to access and drain the bile duct by placement of a stent/drain.

  2. Clinical success [ Time Frame: 180 days ]
    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.

  3. Length of hospital stay [ Time Frame: 180 days ]
    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

  4. Stent/drain patency [ Time Frame: 180 days ]
    Stent/drain patency is measured by the interval (days) between the time of stent placement and stent/drain malfunction or patient death.

  5. Treatment delay [ Time Frame: 180 days ]
    For each severe complication, the treatment team will be asked whether the complication would alter (delay or modify) the pre-existing treatment plan

  6. Time to re-intervention and number of re-interventions [ Time Frame: 180 days ]
  7. Successful training [ Time Frame: 180 days ]
    Successful training defined as significant progress in learning curve calculated by a CUSUM-analysis

  8. Effect of EUS-BD and PTBD on the difficulty of surgery. [ Time Frame: 180 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05519605


Contacts
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Contact: Mike de Jong, MD 0031883207054 mike.dejong@radboudumc.nl
Contact: Erwin van Geenen, MD, PhD 0031243619190 erwin.vangeenen@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Gelderland, Netherlands, 6525GA
Contact: Mike de Jong, MD    +31883207054    mike.dejong@radboudumc.nl   
Contact: Erwin van Geenen, MD, PhD    0031243619190    erwin.vangeenen@radboudumc.nl   
Sponsors and Collaborators
Radboud University Medical Center
More Information
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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT05519605    
Other Study ID Numbers: 113346
First Posted: August 29, 2022    Key Record Dates
Last Update Posted: August 29, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The dataset used during this study is available from the corresponding author upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Neoplasms
Adenocarcinoma
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type