EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
NCT ID: NCT05595122
Last Updated: 2023-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2022-12-02
2024-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
EUS-CDS using FCSEMS through LAMS
EUS-CDS
EUS-CDS with FCSEMS through LAMS
Interventions
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EUS-CDS
EUS-CDS with FCSEMS through LAMS
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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VU University of Amsterdam
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Rogier P. Voermans
Principal Investigator
Locations
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Amsterdam UMC location VUmc
Amsterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Fritzsche JA, Fockens P, Besselink MG, Busch OR, Daams F, Wielenga MCB, Wilmink JW, Voermans RP, Van Wanrooij RLJ. Optimizing EUS-guided choledochoduodenostomy with lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-IIp): a prospective pilot study. Gastrointest Endosc. 2025 May;101(5):1009-1016. doi: 10.1016/j.gie.2024.10.012. Epub 2024 Oct 16.
Other Identifiers
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NL81840.029.22
Identifier Type: -
Identifier Source: org_study_id
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