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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
EUS-CDS with FCSEMS through LAMS
Amsterdam UMC location VUmc
Amsterdam, Netherlands
RECRUITINGStentdysfunction after technical successful EUS-CDS
Recurrent jaundice after initial clinical success, ongoing jaundice in combination with remaining dilatation of the bile ducts, or cholangitis.
Time frame: 6 months
Number of participants with technical success of LAMS placement
Successful creation of a choledochoduodenostomy using a LAMS
Time frame: 1 day (directly after intervention)
Number of participants with technical success of FCSEMS through LAMS
Successful placement of FCSEMS through LAMS.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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Time frame: 6 months
Time to stent dysfunction
Is calculated from the moment of stent insertion until stent dysfunction for which a new procedure is required.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Hospitalization
Is defined as the number of days patient was admitted within the first 30 days after the procedure.
Time frame: 30 days
Survival
Is defined by the number of days after EUS-CDS until death. The cause of death will be registered
Time frame: 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
Time frame: 6 months