EUS-guided choledochoduodenostomy (versus ERCP) for primary drainage of malignant distal biliary obstruction: a pilot study
- Conditions
- Adult patients with malignant distal biliary obstruction that require biliary decompression.
- Registration Number
- NL-OMON23030
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 21
Radiographically (CT or EUS) distal malignant bile duct obstruction.
- Histology or cytology proven malignancy of the primary tumour or metastasis; onsite cytology evaluation after EUS guided fine-needle sampling that is highly suspected of a malignancy suffices.
- Indication for biliary drainage; in case of an resectable tumour this should be discussed during a clinical multidisciplinary meeting.
Written informed consent.
- Age < 18 year.
- Surgically altered anatomy after previous gastric, periampullary or duodenal resection.
- Cancer extending into the antrum or proximal duodenum.
- Extensive liver metastases.
- WHO performance score of 4 (in bed 100% of time).
- Uncorrectable coagulopathy, defined by INR>1.5 or platelets < 50 x 109/L.
- Clinically relevant gastric-outlet obstruction.
- Unable to complete sign informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish the technical success of EUS-CD for the primary drainage of malignant distal biliary obstruction. Technical success is defined as successful creation of a choledochoduodenostomy using a LAMS, which is directly confirmed by a cholangiogram.
- Secondary Outcome Measures
Name Time Method - What is the clinical success rate of EUS-CD?<br>- What is the procedure time of EUS-CD?<br>- What is the adverse events rate of EUS-CD?<br>- What is the delayed time to treatment (surgery, chemo- or radiotherapy) due to adverse events after EUS-CD?<br>- What is the stent patency of EUS-CD?<br>- What is the need for reinterventions of EUS-CD?<br>- What is the overall survival time after EUS-CD?<br>- What are intraoperative findings and difficulties after EUS-CD?<br>- What are the costs involved with EUS-CD?