Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)

Launched by HELSINKI UNIVERSITY CENTRAL HOSPITAL · Sep 20, 2021

Keywords

ClinConnect Summary

The SHODBADI clinical trial is studying a new method for removing large stones from the bile duct, which can cause serious issues like pancreatitis or infections. Researchers are looking at how well this method works when doctors use a special technique to quickly open up the bile duct for just 30 to 60 seconds, right after they see a specific change on an imaging test. The main goals are to see how effectively the stones are removed and to monitor any potential side effects, such as bleeding or new stones forming.

To participate in this trial, you need to be over 18 years old and have a large bile duct stone that is more than 10 millimeters in size. However, if you've had certain types of surgery, have specific health conditions, or are pregnant, you may not be eligible. If you join the study, you can expect to receive the new treatment while being closely monitored for any issues during and after the procedure. This trial is currently recruiting participants and is open to individuals of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>18 years
• • Common bile duct stone \>10mm diameter
• Exclusion Criteria:
• • Altered anatomy after surgery (B II, Roux-en-Y reconstruction)
• • Common bile duct cysts
• • Acute pancreatitis
• • Distal common bile duct stricture or tumor
• • Coagulation disorders
• • Ongoing coagulation medication
• • Pregnancy
• • Inability to give an informed consent