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

Last updated: July 19, 2023
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Biliary Tract Cancer

Abdominal Cancer

Digestive System Neoplasms

Treatment

EUS-CDS

Clinical Study ID

NCT05595122
NL81840.029.22
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Radiographically (CT or EUS) distal malignant bile duct obstruction
  • Histology or cytology proven malignancy of the primary tumour or metastasis; onsitecytology evaluation after EUS guided fine-needle sampling that is highly suspected ofa malignancy suffices
  • Indication for biliary drainage; in case of a resectable tumour this should bediscussed during a clinical multidisciplinary meeting
  • Written informed consent

Exclusion

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 tolocal protocol and treating physician.

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: EUS-CDS
Phase:
Study Start date:
December 02, 2022
Estimated Completion Date:
March 01, 2024

Connect with a study center

  • Amsterdam UMC location VUmc

    Amsterdam, 1081HV
    Netherlands

    Active - Recruiting

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