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

Recruiting

Conditions: Perihilar cholangiocarcinoma (pCCA), galbladder carcinoma (GBC), intrahepatic cholangiocarcinoma (iCCA)

Registration Number: NL-OMON22038

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 37

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the following 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 >100 mmol/l, and/or jaundice and/or loss of appetite and/or dark urine and/or steatorrhea)
Or
• Age > 70 years

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
• 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 *109/L) without clinical or radiological evidence of acute cholecystitis (14). Patients who underwent ERCP are eligible, providing no papillotomy was performed or stent was placed and there are no signs of cholangitis.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Objectives:<br>6-months overall survival.

Secondary Outcome Measures

Name	Time	Method
Secondary Objective(s):<br>• Stent-related complications according to Clavien-Dindo grading system within 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>• Bile culture results.<br>• Proportion of patients that started with palliative chemotherapy;<br>• Cost-effectiveness.<br>• Quality of Life (QoL). – for expansion cohort only