EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction (SCORPION-II-p)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreas Neoplasm; Distal Cholangiocarcinoma; Biliary Obstruction
• Intervention / Treatment: Device: EUS-CDS

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeska Fritzsche; Phone Number: +3120440613; Email: j.a.fritzsche@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1081HV
    • Recruiting
    • Amsterdam UMC Location VUMC
    • Contact: Jeska Fritzsche, MD; Email: j.a.fritzsche@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; EUS-CDS using FCSEMS through LAMS	Device: EUS-CDS; EUS-CDS with FCSEMS through LAMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: VU University of Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: October 22, 2022
• First Submitted That Met QC Criteria: October 22, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Cholangiocarcinoma
• Other Study ID Numbers: NL81840.029.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No