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

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

Recruiting
18 years and older
All
Phase N/A

Overview

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.

Eligibility

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.

Print
Study details
    Biliary Obstruction
    Pancreas Neoplasm
    Distal Cholangiocarcinoma

NCT05595122

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

13 December 2024

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