Biliary ObstructionSCORPION-II-pNCT05595122
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
A study testing EUS-CDS in people with Biliary Obstruction and Pancreas Neoplasm, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Obstruction, Pancreas Neoplasm, Distal Cholangiocarcinoma
- What is being tested?
- EUS-CDS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Dec 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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*
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC location VUmc
Amsterdam, 1081HV
Jeska Fritzsche, MD, j.a.fritzsche@amsterdamumc.nl
About this study
Official title: EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction: a Pilot Study Using FCSEMS Through LAMS
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.
- Being tested
- EUS-CDS
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-CDSDevice
EUS-CDS with FCSEMS through LAMS
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | EUS-CDS using FCSEMS through LAMS Receives: Device: EUS-CDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (11)
Number of participants with technical success of LAMS placement
Successful creation of a choledochoduodenostomy using a LAMS
Measured: 1 day (directly after intervention)
Number of participants with technical success of FCSEMS through LAMS
Successful placement of FCSEMS through LAMS.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6 months
Time to stent dysfunction
Is calculated from the moment of stent insertion until stent dysfunction for which a new procedure is required.
Measured: 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.
Measured: 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.
Measured: 6 months
Hospitalization
Is defined as the number of days patient was admitted within the first 30 days after the procedure.
Measured: 30 days
Survival
Is defined by the number of days after EUS-CDS until death. The cause of death will be registered
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start2 Dec 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- VU University of Amsterdam
- Responsible party
- Principal investigator, Rogier P. Voermans, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595122
- Sponsor's protocol ID
- NL81840.029.22
- Acronym
- SCORPION-II-p
- Status last verified
- Jul 2023
- First submitted
- 22 Oct 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39424003
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction: a Pilot Study Using FCSEMS Through LAMS
- ClinicalTrials.gov ID
- NCT05595122
- Acronym / sponsor ID
- SCORPION-II-p / NL81840.029.22
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- VU University of Amsterdam
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: EUS-CDSEUS-CDS using FCSEMS through LAMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-CDSEUS-CDS with FCSEMS through LAMS | Device | Intervention |
Primary outcome
Stentdysfunction after technical successful EUS-CDS
Time frame: 6 months
Recurrent jaundice after initial clinical success, ongoing jaundice in combination with remaining dilatation of the bile ducts, or cholangitis.
11 secondary outcomes
Number of participants with technical success of LAMS placement
Time frame: 1 day (directly after intervention)
Number of participants with technical success of FCSEMS through LAMS
Time frame: 1 day (directly after intervention)
Number of participants with clinical success
Time frame: 14 days
Procedure time
Time frame: 1 day (directly after intervention)
Adverse events
Time frame: 6 months
Time to stent dysfunction
Time frame: 6 months
Number of re-interventions
Time frame: 6 months
Time to start treatment (chemotherapy or surgery)
Time frame: 6 months
Hospitalization
Time frame: 30 days
Survival
Time frame: 6 months
Costs
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 39424003Fritzsche 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-CDS in people with Biliary Obstruction and Pancreas Neoplasm, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeska Fritzsche (+3120440613, j.a.fritzsche@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stentdysfunction after technical successful EUS-CDS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.