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

Not Applicable

Recruiting

• Conditions: Pancreas Neoplasm; Distal Cholangiocarcinoma; Biliary Obstruction
• Interventions: Device: EUS-CDS

• Registration Number: NCT05595122
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-22
• Study First Submitted QC: 2022-10-22
• Study First Posted: 2022-10-26
• Study Start: 2022-12-02
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20
• Primary Completion: 2023-09-30
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	EUS-CDS	EUS-CDS using FCSEMS through LAMS

Primary Outcome Measures

Name	Time	Method
Stentdysfunction after technical successful EUS-CDS	6 months	Recurrent jaundice after initial clinical success, ongoing jaundice in combination with remaining dilatation of the bile ducts, or cholangitis.

Secondary Outcome Measures

Name	Time	Method
Survival	6 months	Is defined by the number of days after EUS-CDS until death. The cause of death will be registered
Number of participants with technical success of FCSEMS through LAMS	1 day (directly after intervention)	Successful placement of FCSEMS through LAMS.
Time to stent dysfunction	6 months	Is calculated from the moment of stent insertion until stent dysfunction for which a new procedure is required.
Number of participants with technical success of LAMS placement	1 day (directly after intervention)	Successful creation of a choledochoduodenostomy using a LAMS
Number of participants with clinical success	14 days	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	1 day (directly after intervention)	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	6 months	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).
Number of re-interventions	6 months	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)	6 months	Is defined as the number of days after EUS-CDS until initiation of chemotherapy or surgery.
Hospitalization	30 days	Is defined as the number of days patient was admitted within the first 30 days after the procedure.
Costs	6 months	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

Trial Locations

Locations (1)

Amsterdam UMC location VUmc; 🇳🇱 Amsterdam, Netherlands