EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction (NCT05595122) | Clinical Trial Compass
UnknownNot Applicable
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
Netherlands25 participantsStarted 2022-12-02
Plain-language summary
A prospective single-centre pilot study investigating the feasibility and safety of EUS-guided choledochostomy as primary drainage strategy in patients with distal malignant biliary obstruction using a FCSEMS through LAMS to reduce stent dysfunction.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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 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.
What they're measuring
1
Stentdysfunction after technical successful EUS-CDS
Timeframe: 6 months
Trial details
NCT IDNCT05595122
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)