NCT05595122

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 2, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

October 22, 2022

Last Update Submit

July 19, 2023

Conditions

Biliary ObstructionPancreas NeoplasmDistal Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Number of participants with technical success of LAMS placement

    1 day (directly after intervention)

  • Number of participants with technical success of FCSEMS through LAMS

    1 day (directly after intervention)

  • Number of participants with clinical success

    14 days

  • Procedure time

    1 day (directly after intervention)

  • Adverse events

    6 months

  • +6 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

EUS-CDS using FCSEMS through LAMS

Device: EUS-CDS

Interventions

EUS-CDSDEVICE

EUS-CDS with FCSEMS through LAMS

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC location VUmc

Amsterdam, 1081HV, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39424003DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Jeska Fritzsche

CONTACT

+3120440613j.a.fritzsche@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2022

First Posted

October 26, 2022

Study Start

December 2, 2022

Primary Completion

September 30, 2023

Study Completion

March 1, 2024

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

NL(1)