EUS-guided choledochoduodenostomy for primary drainage of malignant distal biliary obstruction: a pilot study using FCSEMS through LAMS

EUS-guided choledochoduodenostomy for primary drainage of malignant distal biliary obstruction: a pilot study using FCSEMS through LAMS - SCORPION-II-pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53481

Enrollment

Registered

2022-10-20

Start date

2022-12-02

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal malignant biliary obstructie

Interventions

All patients will be treated with the investigational treatment (EUS-CDS).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Age 1.5 or platelets

Design outcomes

Primary

Measure	Time frame
The primary endpoint is stent dysfunction.	—

Secondary

Measure	Time frame
Secondary endpoints include technical success, clinical success, procedural time, other adverse events, time to stent dysfunction, need for re-interventions. Patients will be followed up for at least six months, until pancreaticoduodenectomy, or death	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026