Biliary drainage through the skin with metal stent placement in patients with inoperable bile duct cancer.

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56129

Enrollment

112

Registered

2019-10-16

Start date

2020-10-13

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bile duct cancer, Malignant biliary hilar stricture

Interventions

Percutaneous transhepatic biliary drainage, by bridging significant ductal strictures by self-expandable fenestrated metal stents without cannulation of the ampulla.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
6 month overall survival	—

Secondary

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

Measure

Time frame

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

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Countries

Belgium, Netherlands, Norway

Contacts

Public ContactB. Groot Koerkamp

Erasmus MC, Universitair Medisch Centrum Rotterdam

b.grootkoerkamp@erasmusmc.nl0633330948

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)