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
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 600 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for Dec 2025, 56 months after the start.
Of 91 non-industry interventional studies with no phase under Pancreatitis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 56 months is above that.
Counting every sponsor, half of 94 studies reached it within 32 months; a quarter within 23 and three quarters within 59.
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