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2022-12-02
2023-09-30
2024-03-01
25
NCT05595122
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
INTERVENTIONAL
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-10-22 | N/A | 2023-07-19 |
2022-10-22 | N/A | 2023-07-20 |
2022-10-26 | N/A | 2023-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Intervention EUS-CDS using FCSEMS through LAMS | DEVICE: EUS-CDS
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Stentdysfunction after technical successful EUS-CDS | Recurrent jaundice after initial clinical success, ongoing jaundice in combination with remaining dilatation of the bile ducts, or cholangitis. | 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of participants with technical success of LAMS placement | Successful creation of a choledochoduodenostomy using a LAMS | 1 day (directly after intervention) |
| Number of participants with technical success of FCSEMS through LAMS | Successful placement of FCSEMS through LAMS. | 1 day (directly after intervention) |
| Number of participants with clinical success | 50% decrease or normalization of bilirubin level within 14 days of the procedure. Presumed persistant hepatic secretory failure with ongoing jaundice but decreased diameter of the bile ducts and decrease of ALT, alkaline phosphatase and gamma-glutamyl transpeptidase is not considered clinical failure of the intervention. | 14 days |
| Procedure time | Is measured from introduction of endoscope in the patient until removal of endoscope after completion of the procedure. In case a fine needle aspiration (FNA) or biopsy (FNB) needs to be taken from the primary tumour to confirm malignancy, time is measured after completion of this procedure. | 1 day (directly after intervention) |
| Adverse events | Are defined as any probably or definitely procedure- or admission related adverse event occurring after EUS-CDS. Severity will be recorded and graded NL81840.029.22 version 1.1 08-08-2022 SCORPION-II-pilot study 23 of 45 (mild, moderate, severe or fatal) according to the ASGE lexicon.(23) Common or expected AEs are defined according to the ASGE lexicon (including the following categories: cardiovascular, pulmonary, thromboembolic, perforation, bleeding, infection, pain). | 6 months |
| Time to stent dysfunction | Is calculated from the moment of stent insertion until stent dysfunction for which a new procedure is required. | 6 months |
| Number of re-interventions | Is defined as any unplanned intervention (endoscopic, intervention radiology or surgical) for an adverse event, persistent jaundice or recurrent obstructive symptoms, that is needed after EUS-CDS. | 6 months |
| Time to start treatment (chemotherapy or surgery) | Is defined as the number of days after EUS-CDS until initiation of chemotherapy or surgery. | 6 months |
| Hospitalization | Is defined as the number of days patient was admitted within the first 30 days after the procedure. | 30 days |
| Survival | Is defined by the number of days after EUS-CDS until death. The cause of death will be registered | 6 months |
| Costs | Are defined as the intramural costs that were involved with EUS-CDS, collected from the electronic hospital records and linked to the Dutch unit costs | 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jeska Fritzsche Phone Number: +3120440613 Email: j.a.fritzsche@amsterdamumc.nl |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
