Back to resultsEUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction (SCORPION-II-p)
Primary Purpose
Biliary Obstruction, Pancreas Neoplasm, Distal Cholangiocarcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
EUS-CDS
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Obstruction
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.
Sites / Locations
- Amsterdam UMC location VUmcRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
EUS-CDS using FCSEMS through LAMS
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of participants with technical success of LAMS placement
Successful creation of a choledochoduodenostomy using a LAMS
Number of participants with technical success of FCSEMS through LAMS
Successful placement of FCSEMS through LAMS.
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.
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.
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).
Time to stent dysfunction
Is calculated from the moment of stent insertion until stent dysfunction for which a new procedure is required.
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 to start treatment (chemotherapy or surgery)
Is defined as the number of days after EUS-CDS until initiation of chemotherapy or surgery.
Hospitalization
Is defined as the number of days patient was admitted within the first 30 days after the procedure.
Survival
Is defined by the number of days after EUS-CDS until death. The cause of death will be registered
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
Full Information
NCT ID
NCT05595122
First Posted
October 22, 2022
Last Updated
July 19, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
VU University of Amsterdam
1. Study Identification
Unique Protocol Identification Number
NCT05595122
Brief Title
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
Acronym
SCORPION-II-p
Official Title
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction: a Pilot Study Using FCSEMS Through LAMS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
VU University of Amsterdam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Obstruction, Pancreas Neoplasm, Distal Cholangiocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
EUS-CDS using FCSEMS through LAMS
Intervention Type
Device
Intervention Name(s)
EUS-CDS
Intervention Description
EUS-CDS with FCSEMS through LAMS
Primary Outcome Measure Information:
Title
Stentdysfunction after technical successful EUS-CDS
Description
Recurrent jaundice after initial clinical success, ongoing jaundice in combination with remaining dilatation of the bile ducts, or cholangitis.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants with technical success of LAMS placement
Description
Successful creation of a choledochoduodenostomy using a LAMS
Time Frame
1 day (directly after intervention)
Title
Number of participants with technical success of FCSEMS through LAMS
Description
Successful placement of FCSEMS through LAMS.
Time Frame
1 day (directly after intervention)
Title
Number of participants with clinical success
Description
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
Title
Procedure time
Description
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)
Title
Adverse events
Description
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).
Time Frame
6 months
Title
Time to stent dysfunction
Description
Is calculated from the moment of stent insertion until stent dysfunction for which a new procedure is required.
Time Frame
6 months
Title
Number of re-interventions
Description
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
Title
Time to start treatment (chemotherapy or surgery)
Description
Is defined as the number of days after EUS-CDS until initiation of chemotherapy or surgery.
Time Frame
6 months
Title
Hospitalization
Description
Is defined as the number of days patient was admitted within the first 30 days after the procedure.
Time Frame
30 days
Title
Survival
Description
Is defined by the number of days after EUS-CDS until death. The cause of death will be registered
Time Frame
6 months
Title
Costs
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeska Fritzsche
Phone
+3120440613
Email
j.a.fritzsche@amsterdamumc.nl
Facility Information:
Facility Name
Amsterdam UMC location VUmc
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeska Fritzsche, MD
Email
j.a.fritzsche@amsterdamumc.nl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
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