To reduce stent dysfunction after EUS-CDS by placing a FCSEMS through the LAMS, while maintaining effectiveness and safety of EUS-CDS as primary drainage strategy in patients with malignant distal biliary obstruction.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is stent dysfunction.
Secondary outcome
Secondary endpoints include technical success, clinical success, procedural
time, other adverse events, time to stent dysfunction, need for
re-interventions. Patients will be followed up for at least six months, until
pancreaticoduodenectomy, or death
Background summary
Endoscopic retrograde cholangiopancreatography (ERCP) has been the primary
approach to decompress the bile duct in patients with a malignant biliary
obstruction. However, complications of ERCP such as post-procedural
pancreatitis (3.5 - 19%), bleeding (0.3 - 9%), cholangitis (0.5 - 11%),
cholecystitis (0.5 - 5.2%) and perforation (0.08-2%) are not uncommon.(1, 2)
Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) 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). By
bypassing the pancreas EUS-CDS does not lead to post-procedural pancreatitis.
In previous performed pilot study the effectiveness and safety of EUS-CDS has
been shown in 21 patients. The high technical success rate (91%) and lack of
pancreatitis in this study were satisfying. Unfortunately, stent dysfunction
due to either food impaction or presumed obstruction of the stent by the
contralateral bile duct wall occurred more often than expected (30-40%).
Presumably the short length and perpendicular angle of the stent to the bile
duct contribute to the risk of stent dysfunction. Therefore, a second pilot
study will investigate whether placement of a fully covered self-expandable
metal stent (FCSEMS) through the LAMS, which will create a barrier between bile
ducts and duodenum as well as optimize the angle of the stent, will decrease
the risk of stent dysfunction while maintaining high technical success and low
adverse event rates.
Study objective
To reduce stent dysfunction after EUS-CDS by placing a FCSEMS through the LAMS,
while maintaining effectiveness and safety of EUS-CDS as 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-CDS).
Study burden and risks
Participation in this therapeutic study offers patients with malignant biliary
obstruction the opportunity to undergo EUS-CDS as the primary drainage
strategy. The burden and risk of EUS-CDS are expected to be lower than those of
the standard treatment (ERCP). Follow-up is according to standard of care,
telephonic consult and laboratory tests 2 weeks, 1 month, and every 3 months
after the procedure.
Boelelaan 1118
Amsterdam 1081 HV
NL
Boelelaan 1118
Amsterdam 1081 HV
NL
Listed location countries
Age
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 a resectable tumour this should
be discussed during a clinical multidisciplinary meeting
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 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81840.029.22 |