EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction (SCORPION-II-p)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status

Enrolling

Conditions

Distal Cholangiocarcinoma

Biliary Obstruction

Pancreas Neoplasm

Treatments

Device: EUS-CDS

Study type

Interventional

Funder types

Other

Identifiers

NCT05595122

NL81840.029.22

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.