Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: endoscopic short duration papillary large balloon dilation.
- Who it may be relevant to
- Registry conditions: Pancreatitis, Acute, Bleeding, Cholangitis. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endoscopic Papillary Short Duration Large Balloon Dilatation for Removal of Large Bile Duct Stones: a Prospective Multicenter Study of Short and Long-term Adverse Events
Overview
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.
Detailed description
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:
1. EST and stone extraction 2. EPLBD when EST and stone extraction did not succeed 3. Short EST and EPLBD
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
Interventions
- 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.
Primary outcome measures
- Rate of bleeding [Time frame: 30 days]
- Rate of pancreatitis [Time frame: 30 days]
- Rate of cholangitis [Time frame: 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 2 centers
- Helsinki University Hospital — Helsinki
- Turku University Hospital — Turku
Identifiers
NCT: NCT05061680 · Largeballoon dilation