Clinical trial · Interventional
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction: a Pilot Study Using FCSEMS Through LAMS
NCT05595122CI-TRIAL-00068116SCORPION-II-punknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Obstruction | — | UNRESOLVED | — |
| Distal Cholangiocarcinoma | Distal Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreas Neoplasm | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS-CDS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- EUS-CDS using FCSEMS through LAMS
- interventionNames
- Device: EUS-CDS
Primary outcomes (1)
- measure
- Stentdysfunction after technical successful EUS-CDS
- timeFrame
- 6 months
- description
- Recurrent jaundice after initial clinical success, ongoing jaundice in combination with remaining dilatation of the bile ducts, or cholangitis.
Secondary outcomes (11)
- measure
- Number of participants with technical success of LAMS placement
- timeFrame
- 1 day (directly after intervention)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFritzsche 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 39424003