Clinical trial NCT05519605: Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD
Official title: Bile Duct Drainage After ERCP Failure: EUS-guided Biliary Versus Percutaneous Transhepatic Drainage
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Cancer
Cholangiocarcinoma
Biliary Obstruction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Complications of PTBD vs EUS-BD
timeFrame: 180 days
Secondary outcomes:
measure: Technical success of the initial procedure
timeFrame: 180 days
measure: Clinical success
timeFrame: 180 days
measure: Length of hospital stay
timeFrame: 180 days
measure: Stent/drain patency
timeFrame: 180 days
measure: Treatment delay
timeFrame: 180 days
measure: Time to re-intervention and number of re-interventions
timeFrame: 180 days
measure: Successful training
timeFrame: 180 days
measure: Effect of EUS-BD and PTBD on the difficulty of surgery.
timeFrame: 180 days
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: