EUS-guided choledochoduodenostomy for primary drainage of malignant distal biliary obstruction: a pilot study using FCSEMS through LAMS
- Conditions
- Distal malignant biliary obstructie10019815
- Registration Number
- NL-OMON53481
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
- 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 a resectable tumour this should
be discussed during a clinical multidisciplinary meeting
- 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 10^9/L*
- Clinically relevant gastric-outlet obstruction
- Unable to complete sign informed consent
* Inclusion is allowed after corrective treatment measures are taken, according
to local protocol and treating physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is stent dysfunction.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include technical success, clinical success, procedural<br /><br>time, other adverse events, time to stent dysfunction, need for<br /><br>re-interventions. Patients will be followed up for at least six months, until<br /><br>pancreaticoduodenectomy, or death</p><br>