EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction

Biliary Obstruction Clinical Trial

— SCORPION-II-p  

Official title:

EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction: a Pilot Study Using FCSEMS Through LAMS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595122
• Other study ID #: NL81840.029.22
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Jeska Fritzsche
• Phone: +3120440613
• Email: j.a.fritzsche[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 1, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Obstruction
• Cholangiocarcinoma
• Pancreas Neoplasm
• Pancreatic Neoplasms

Intervention

Device:
• EUS-CDS
EUS-CDS with FCSEMS through LAMS

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC location VUmc	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with technical success of LAMS placement	Successful creation of a choledochoduodenostomy using a LAMS	1 day (directly after intervention)
Secondary	Number of participants with technical success of FCSEMS through LAMS	Successful placement of FCSEMS through LAMS.	1 day (directly after intervention)
Secondary	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
Secondary	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)
Secondary	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
Secondary	Time to stent dysfunction	Is calculated from the moment of stent insertion until stent dysfunction for which a new procedure is required.	6 months
Secondary	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
Secondary	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
Secondary	Hospitalization	Is defined as the number of days patient was admitted within the first 30 days after the procedure.	30 days
Secondary	Survival	Is defined by the number of days after EUS-CDS until death. The cause of death will be registered	6 months
Secondary	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