EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction

EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction: a Pilot Study Using FCSEMS Through LAMS

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.

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.