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Trial Title:
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
NCT ID:
NCT05595122
Condition:
Biliary Obstruction
Pancreas Neoplasm
Distal Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
EUS-CDS
Description:
EUS-CDS with FCSEMS through LAMS
Arm group label:
Intervention
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Amsterdam UMC location VUmc
Address:
City:
Amsterdam
Zip:
1081HV
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jeska Fritzsche, MD
Email:
j.a.fritzsche@amsterdamumc.nl
Start date:
December 2, 2022
Completion date:
March 1, 2024
Lead sponsor:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Collaborator:
Agency:
VU University of Amsterdam
Agency class:
Other
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05595122
