Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorHelsinki University Central Hospital
About this trial
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
Qualifiers
Age >18 years
Common bile duct stone >10mm diameter
Disqualifiers
Altered anatomy after surgery (B II, Roux-en-Y reconstruction)
Common bile duct cysts
Acute pancreatitis
Distal common bile duct stricture or tumor
Trial design
Treatments tested in this trial
- endoscopic short duration papillary large balloon dilation
Treatment groups
600 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov