Treatment of Distal Malignant Biliary Obstruction by Uncovered, Partially Covered, or Fully Covered Metal Stents

Launched by REGION STOCKHOLM · Jun 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at different types of metal stents, which are small tubes used to keep blocked bile ducts open for patients with advanced cancers like pancreatic and bile duct cancer. Researchers want to find out if the type of stent—uncovered, partially covered, or fully covered—affects how long it stays open (patency), how long patients live after getting the stent, and what complications might arise. The study will include 450 patients who meet specific criteria, such as being over 20 years old and having a certain type of bile duct blockage.

Participants in the trial will have a procedure called ERCP, where doctors will insert one of the stents and will be monitored monthly by a study nurse for up to a year. They will be informed about the study and must agree to participate. This trial is currently recruiting, and it aims to provide valuable insights into the best options for managing bile duct obstructions caused by cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient age \> 20 years.
• • The biliary stenosis located \> 2 cm below the hilum of the liver, and with a malignant appearance.
• • The patient history, and clinical data supporting a malignant bile duct stenosis.
• • S-Bilirubin \> 50 μmol/L.
• • Curative surgery or down-staging not possible due to an advanced decease, or surgery is precluded by high age or co-morbidity. Temporary placement of a plastic endoprosthesis allowed, and after reevaluation within 4 weeks the patient may enter the study.
• • The patient has received oral and written information about the study and accepted to participate.
• • CT and/or Ultrasound has been performed.
• Exclusion Criteria:
• • Informed consent has not been obtained or denied.
• • The presence of significant intrahepatic stenoses caused by metastatic disease with also intrahepatic obstruction of the bile flow. A malignant stenosis in the hilum of the liver, or a tumor stricture located \< 2cm below the hilum of the liver.
• • The patient is probably a candidate for curative surgery or down-staging.
• • Suspicion of a benign biliary obstruction.
• • Anatomical situation making ERCP impossible i.e. prior surgical interventions or a tumor stenosis of the duodenum. If the ERCP is not successful at the first attempt a repeated procedure or a PTC rendezvouz is allowed within one week.
• • Prior biliary drainage (\> 4 weeks earlier).
• • Increased risk of bleeding (INR \>1.5)
• • The patient has previously been included in the study.