To establish the effectiveness and safety of EUS-CD as the primary drainage strategy in patients with malignant distal biliary obstruction.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Bile duct disorders
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is technical success.
Secondary outcome
Secondary endpoint are clinical success, procedural time, adverse events, stent
patency, need for reinterventions, technical outcome at pancreaticoduodenectomy
(when applicable), and cost.
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 78%.[1]
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.[2] Endoscopic ultrasound-guided
choledochoduodenostomy (EUS-CD) is a relatively new technique that allows the
endoscopist to create a bypass between the bile duct and the duodenum by
placing a lumen apposing metal stent (LAMS). 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.[3-5] 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
To establish the effectiveness and safety of EUS-CD as the primary drainage
strategy in patients with malignant distal biliary obstruction.
Study design
Prospective, monocenter, single-arm, interventional, pilot study
Intervention
All patients will be treated with the investigational treatment (EUS-CD).
Study burden and risks
Participation in this therapeutic study offers patients with malignant biliary
obstruction the opportunity to undergo EUS-CD as the primary drainage strategy.
The burden and risk of EUS-CD are expected to be lower than those of the
standard treatment (ERCP). The burden of follow-up within this study is limited
and mainly concerns follow-up phone calls and laboratory tests 2 weeks, 1
month, and every 3 months after the procedure that evaluates whether stent
related problems have occurred.
de Boelelaan 1118
Amsterdam 1081hz
NL
de Boelelaan 1118
Amsterdam 1081hz
NL
Listed location countries
Age
Inclusion criteria
- Radiographically (CT, 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
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77539.029.21 |
| OMON | NL-OMON23030 |