Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction

NCT06671418 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: Erasmus MC TESLA RCT
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cholangiocarcinoma Non-resectable; Gall Bladder Cancer; Liver Metastasis; Malignant Hilar Stricture

Outcome Measures

Primary Outcomes (1)

• Major complications within 90 days after randomisation

  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.

  90 days after randomization

Study Arms (2)

Endoscopic biliary drainage (standard of care)

OTHER

Procedure: Endoscopic biliary drainage

Primary percutaneous stenting

ACTIVE COMPARATOR

Procedure: Primary percutaneous stenting (PPS)

Interventions

Primary percutaneous stenting (PPS) PROCEDURE

PPS bridging malignant hilar biliary obstruction with self-expandable uncovered metal stents without crossing the ampulla and without leaving an external drain. The procedure is performed by an interventional radiologist who has performed at least 5 PPS procedures.

Primary percutaneous stenting

Endoscopic biliary drainage PROCEDURE

EBD according to the American Society for Gastrointestinal Endoscopy (ASGE) guidelines of 2021. The procedure is performed by a gastro-enterologist who is experienced in performing EBD in patients with a MHBO.

Endoscopic biliary drainage (standard of care)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

Location

Related Publications (1)

• Rousian 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 DERIVED

MeSH Terms

Conditions

Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: August 9, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)