Primary percutaneous placement of metal stents for palliative biliary drainage in patients with a primary malignant perihilar stricture

Phase 2

Recruiting

Conditions: bile duct cancer
Malignant biliary hilar stricture
10004606

Registration Number: NL-OMON56129

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 112

Inclusion Criteria

• Written informed consent must be given according to ICH/GCP, and
national/local regulations.
• Unresectable primary malignant perihilar obstruction on imaging with
histopathological confirmation or high clinical suspicion (as determined by the
multidisciplinary hepatobiliary team)
And
• Symptomatic hyperbilirubinemia (a combination of a total bilirubin level >20
mmol/l, and/or jaundice and/or loss of appetite and/or dark urine and/or
steatorrhea)

Exclusion Criteria

• Fluctuation or spontaneous decrease of a total bilirubin level before start
of any treatment suggesting potential benign origin.
Patients who underwent previous drainage procedures endoscopically or
percutaneously with an internalized biliary catheter
• Clinical signs of cholangitis. Cholangitis was defined as both fever (i.e.
body temperature >38.5°C) and leucocytosis (i.e. >=10 *10^9/L) without clinical
or radiological evidence of acute cholecystitis. Patients who underwent ERCP
are eligible, providing no papillotomy was performed and there are no signs of
cholangitis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>6 month overall survival</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Stent-related complications according to Clavien-Dindo grading system within<br />90 days.<br />• Absolute and relative (%) bilirubin decrease after 14 days.<br />• Number of scheduled and unscheduled reinterventions within 90 days.•<br />Infectious biliary complications (i.e. cholangitis and cholecystitis)<br />• Technical success of stent placement at initial drainage procedure<br />• 90-day mortality after initial biliary drainage<br />• Bile culture results<br />• Quality of life, measured with the EORTC Quality of Life Questionnaire C-30<br />(QLQ-C30) and its biliary cancer module (QLQ-BIL21);<br />• Proportion of patients that started with palliative chemotherapy.<br />• Cost-effectiveness</p>