Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?
Key facts
- Who runs it
- Helsinki University Central Hospital
- Where
- Finland1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Started
- 18 Nov 2017
- Ended
- Dec 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Tannenbaum 10 Fr biliary stent
- Self-expandable metallic biliary stent
- Record updated
- 19 May 2021
- Why it stopped
- Investigators busy with other projects at the moment
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Resectable tumor of the head of the pancreas
- Elevated serum bilirubin levels
- Radiologically visible dilatation of the biliary system
Who cannot take part
- Inoperable tumor or other reason, why the patient is unfit for surgery
- Distant metastasis
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded.
Read full original descriptionShow less
This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.
The 2 groups in the trial
- Plastic biliary stentTreatment being tested
A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression
Treatment: Tannenbaum 10 Fr biliary stent
- Self-expandable metallic biliary stentTreatment being tested
A self-expandable metallic biliary stent is used to achieve biliary decompression
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 19 May 2021