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| Name | Class |
|---|---|
| VU University of Amsterdam | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | EUS-CDS using FCSEMS through LAMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS-CDS | Device | EUS-CDS with FCSEMS through LAMS |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeska Fritzsche | Contact | +3120440613 | j.a.fritzsche@amsterdamumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC location VUmc | Recruiting | Amsterdam | 1081HV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39424003 | Derived | 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. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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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 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |