Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction.

Recruiting

• Conditions: bile duct cancer; Malignant hilar biliary obstruction; 10004606

• Registration Number: NL-OMON53463
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 148

Inclusion Criteria

• Written informed consent must be given according to ICH/GCP and
national/local regulations.
And
• MHBO on imaging with histopathological confirmation or high clinical
suspicion.
And
• Ineligible for surgical resection.
And
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Major complications within 90 days after randomization </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The total number of severe drainage-related complications within 90 days after<br /><br>randomisation, OS, absolute and relative (%) total bilirubin decrease after 14<br /><br>days (+/- 4 days), the proportion of patients with technical success of stent<br /><br>placement at initial drainage procedure, the proportion of patient with<br /><br>successful drainage at initial drainage procedure, the number of<br /><br>reinterventions within 90 days after randomization that involved (attempted)<br /><br>stent (re-)placement, the number of hospital admission days within 90 days<br /><br>after randomization, the proportion of patients requiring crossover treatment,<br /><br>the proportion of patients that become eligible for palliative chemotherapy,<br /><br>QoL and cost-effectiveness. </p><br>