NCT05061680 Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)
| NCT ID | NCT05061680 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helsinki University Central Hospital |
| Condition | Pancreatitis, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2021-04-05 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2021-04-05 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
ESGE guidelines suggests 30-60 seconds endoscopic large balloon papillary dilation from the disappearance of the waist of the papilla. The investigators have good results in stone removal with much quicker dilatations when the cholangiogram is followed and the dilation is finished as soon as the disappearance of the waist of the papilla is seen. This Scandinavian multicenter prospective study is especially interested in stone clearance rate and short and long-term adverse events such as pancreatitis, cholangitis, bleeding, perforations, residual biliary stones, and newly developing biliary stones.
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
Contact & Investigator
Mia Rainio, Md, PhD
STUDY DIRECTOR
Helsinki University Central Hospital
Frequently Asked Questions
Who can join the NCT05061680 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 95 Years, studying Pancreatitis, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05061680 currently recruiting?
Yes, NCT05061680 is actively recruiting participants. Contact the research team at mia.rainio@hus.fi for enrollment information.
Where is the NCT05061680 trial being conducted?
This trial is being conducted at Helsinki, Finland, Turku, Finland.
Who is sponsoring the NCT05061680 clinical trial?
NCT05061680 is sponsored by Helsinki University Central Hospital. The principal investigator is Mia Rainio, Md, PhD at Helsinki University Central Hospital. The trial plans to enroll 600 participants.