Health TrialsbyHealthPanel

Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)

ConditionsPancreatitis, AcuteBleedingCholangitis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • endoscopic short duration papillary large balloon dilation

    Device

    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.

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: short sphincterotomy +Short duration papillary large balloon dilationActive comparator 1 intervention
Group B: full sphincterotomy + short duration papillary balloon dilationActive comparator 1 intervention
Group C: previous sphincterotomy + short duration papillary balloon dilationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of bleeding

need for additional intervention or need for blood transfusion and hemoglobin drop more than 2 gm/dL

Time frame
30 days
2

Rate of pancreatitis

Plasma amylase rises \>3 times the upper limit and newly developed stomach ace more than 24h

Time frame
30 days
3

Rate of cholangitis

Fever \>38

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helsinki University Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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