Clinical trial · Interventional
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)
- 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)
The goal of this clinical randomized controlled trial is to perform primary percutaneous stenting (PPS) in patients with malignant hilar biliary obstruction (MHBO). The main question it aims to answer is: To compare the efficacy of PPS above the ampulla to standard endoscopic biliary drainage (EBD) in patients with a MHBO who are ineligible for surgical resection. Researchers will compare PPS with EBD to see if major complications within 90 days after randomisation occur. Participants will undergo either primary percutaneous stenting or endoscopic biliary drainage, depending on randomization.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma Non-resectable | — | UNRESOLVED | — |
| Gall Bladder Cancer | — | UNRESOLVED | — |
| Liver Metastasis | — | UNRESOLVED | — |
| Malignant Hilar Stricture | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic biliary drainage | Procedure | — | UNRESOLVED |
| Primary percutaneous stenting (PPS) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Endoscopic biliary drainage (standard of care)
- interventionNames
- Procedure: Endoscopic biliary drainage
- type
- ACTIVE_COMPARATOR
- label
- Primary percutaneous stenting
- interventionNames
- Procedure: Primary percutaneous stenting (PPS)
Primary outcomes (1)
- measure
- Major complications within 90 days after randomisation
- timeFrame
- 90 days after randomization
- description
- The primary objective is to compare major complications within 90 days after randomization of PPS and EBD in patients with MHBO who are ineligible for surgical resection. Major complications are defined as any complication leading to prolonged hospital stay of more than 72 hours, readmission to hospital, invasive reintervention, or death.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Written informed consent must be given according to ICH/GCP and national/local regulations. * MHBO on imaging with histopathological confirmation or high clinical suspicion. * Ineligible for surgical resection. * Hyperbilirubinemia (a combination of a total bilirubin level \>50 mmol/l. Exclusion Criteria: * Fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting a potential non-malignant diagnosis. * Patients who underwent previous biliary drainage procedures endoscopically or percutaneously. Patients who underwent an attempted but failed ERCP are eligible only when no papillotomy or cannulation was performed. * Clinical signs of cholangitis. Cholangitis is defined as the presence of both fever (i.e. body temperature \>38.5°C) and leucocytosis (i.e. ≥10 \*109/L) without clinical or radiological evidence of acute cholecystitis (22). * Uncorrectable coagulation disorder. * Uncorrectable contrast allergy.
References
Publications (1)
- DERIVEDRousian M, van Verschuer V, Franssen S, Bijdevaate D, Bokkers RPH, Braat AE, de Bruijne J, Bruno MJ, Burgmans MC, van Delden OM, Dewulf M, Erdmann JI, Hagendoorn J, van der Holt B, Hoogwater FJH, Inderson A, van der Leij C, Mohseny B, Poley JW, Smits MLJ, van Vilsteren FGI, Voermans RP, Zijlstra IAJ, van Driel LMJW, Koerkamp BG. Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial. BMC Cancer. 2025 May 9;25(1):849. doi: 10.1186/s12885-025-14158-0. PMID 40346549