An interventional study of endoscopic short duration papillary large balloon dilation in Pancreatitis, Acute, Bleeding and Cholangitis, sponsored by Helsinki University Central Hospital. Recruiting at 2 sites in Finland. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
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.
This study is planned as a multicenter Scandinavian prospective study including all the patients >18 years with >10mm diameter common bile duct stones visible in cholangiogram. Before ERCP all patient will be informed about this trial, and if they agree to participate this study, they need to give a written informed consent. The endoscopists will decide whether the first step will be large EST and stone extraction or small EST and dilatation. If simple EST does not success, the dilatation will remain as a rescue method. The diameter of dilatation balloon cannot exceed the diameter of common bile duct above the papilla. Cholangiogram is followed when papilla is dilated and the dilatation will be ended when the waist of the papilla disappears. The duration of the dilatation measured, but it does not define the ending of dilatation. All adverse events will be recorded one month and a year after the procedure.
Classification of the patients:
The investigators will collect the information of adverse events such as bleeding, pancreatitis, cholangitis with patient questionnaire as well as from the patient records one month and a year after the procedure
Exclusion Criteria:
Patients with short sphincterotomy
Device: endoscopic short duration papillary large balloon dilation
Patients with full lenght sphincterotomy
Device: endoscopic short duration papillary large balloon dilation
Patients with previous sphincterotomy
Device: endoscopic short duration papillary large balloon dilation
During the large balloon papillary dilation investigators follow the cholangiogram and stop the dilatation as soon as the disappearance of the waist of the papilla is noticed.
Rate of bleeding
need for additional intervention or need for blood transfusion and hemoglobin drop more than 2 gm/dL
Time frame: 30 days
Rate of pancreatitis
Plasma amylase rises \>3 times the upper limit and newly developed stomach ace more than 24h
Time frame: 30 days
Rate of cholangitis
Fever \>38
Time frame: 30 days
Plan to share: No
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Helsinki University Central Hospital