An observational study in Pancreatic Cancer, Cholangiocarcinoma and Biliary Obstruction, sponsored by Radboud University Medical Center. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Radboud University Medical Center · Observational
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.
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's enrollment of 61 is below the median of 196 across 176 observational studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
Patients with a distal malignant obstruction undergoing placement of a percutaneous transhepatic biliary drain after failed ERCP.
Patients with a distal malignant obstruction undergoing EUS-guided biliary drainage after failed ERCP.
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.
Time frame: 180 days
Technical success of the initial procedure
Defined as: the ability to access and drain the bile duct by placement of a stent/drain.
Time frame: 180 days
Clinical success
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.
Time frame: 180 days
Length of hospital stay
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
Time frame: 180 days
Stent/drain patency
Stent/drain patency is measured by the interval (days) between the time of stent placement and stent/drain malfunction or patient death.
Time frame: 180 days
Treatment delay
For each severe complication, the treatment team will be asked whether the complication would alter (delay or modify) the pre-existing treatment plan
Time frame: 180 days
Time to re-intervention and number of re-interventions
Time frame: 180 days
Successful training
Successful training defined as significant progress in learning curve calculated by a CUSUM-analysis
Time frame: 180 days
Effect of EUS-BD and PTBD on the difficulty of surgery.
Time frame: 180 days
Plan to share: Undecided — The dataset used during this study is available from the corresponding author upon reasonable request.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center