No registrations found.
ID
Source
Brief title
Health condition
Adult patients with malignant distal biliary obstruction that require biliary decompression.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
- What is the clinical success rate of EUS-CD?
- What is the procedure time of EUS-CD?
- What is the adverse events rate of EUS-CD?
- What is the delayed time to treatment (surgery, chemo- or radiotherapy) due to adverse events after EUS-CD?
- What is the stent patency of EUS-CD?
- What is the need for reinterventions of EUS-CD?
- What is the overall survival time after EUS-CD?
- What are intraoperative findings and difficulties after EUS-CD?
- What are the costs involved with EUS-CD?
Background summary
Endoscopic retrograde cholangiopancreatography (ERCP) has been the primary approach to decompress the bile duct in patients with a malignant biliary obstruction. In spite of extensive experience with this technique in the Netherlands the technical success of ERCP in these patients is only 75%. Complications of ERCP such as post-procedural pancreatitis (3,5 - 10%), bleeding (0,3 - 9%), cholangitis (0,5 - 3%), cholecystitis (0,5 - 5,2%) and perforation (0,08-0,6%) are also not uncommon. Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CD) obviates the need to reach the papilla and, in contrast to ERCP, is feasible in patients with duodenal obstruction. By bypassing the pancreas and the tumour EUS-CD does not lead to post-procedural pancreatitis. Three randomized controlled trials in international expert centres in North-America and Asia have compared EUS-CD versus ERCP which showed similar technical success, but lower adverse events and longer stent patency in EUS-BD. More data is needed to assess whether EUS-CD is indeed superior to ERCP as primary drainage strategy in patients with distal malignant biliary obstruction. In this pilot study the effectiveness and safety of EUS-CD will be evaluated in our tertiary referral center, and if satisfactory, a multicentre randomized controlled trial will be initiated.
Study objective
A 95% technical success rate is expected
Study design
Baseline: bilirubin levels
2 weeks after the procedure: consultation and bilirubin levels
4 weeks after the procedure: consultation and bilirubin levels
Every 3 months after the procedure: consultation and bilirubin levels
Patients will be followed up until pancreaticoduodenectomy or death.
Intervention
EUS-guided choledochoduodenostomy
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9757 |
| CCMO | NL77539.029.21 |
| OMON | NL-OMON51255 |