Feasibility and Safety of Bile Duct Clearance by Transcystic Sphincter of Oddi Balloon Dilatation

  • End date
    Jul 31, 2022
  • participants needed
  • sponsor
    University Hospital Inselspital, Berne
Updated on 11 February 2021


To investigate feasibility and safety of intraoperative bile duct clearance by sphincter of Oddi balloon dilatation via cystic duct at cholecystectomy.

Primary endpoint: rate of successful bile duct stone clearance (feasibility). Secondary endpoints (safety): rate of peri-interventional complications (injury to the common bile duct, bleeding, injury to surrounding organs: stomach, duodenum, liver) and short-term postoperative complications (bile leak, cholangitis, lipasaemia, pancreatitis, pneumonia). Duration of procedure. Length of hospital stay.


Standard approach to address common bile duct stones is endoscopic retrograde cholangiography (ERC) with sphincterotomy. Those interventions are performed either before or after gallbladder removal (cholecystectomy), thus, requiring at least two interventions. Moreover, ERC with sphincterotomy is associated with a considerable rate of short and long-term morbidity. The main complications are pancreatitis (2-7%), post sphincterotomy bleeding (1-2%), impaired function of the sphincter with reflux of duodenal content to the bile ducts and a consecutive risk for cholangitis, stone recurrence and even a potential higher risk for cholangiocarcinoma.

The aim of this study is to evaluate an alternative surgical approach of bile duct clearance at the time of cholecystectomy. Literature of this approach is scarce; however, it has shown a trend to lower postoperative complications if compared to ERC. The technique of sphincter of Oddi balloon dilatation and bile duct clearance from stones via cystic duct at cholecystectomy has been described in a few case series. These small case series have shown a good success rate of bile stone clearance and low complication rates when applying the balloon dilation technique for smaller stones.

The investigators have used this technique in selected cases with good success as well. However, the technique needs to be assessed regarding feasibility and safety in a consecutive group of patients.

Condition Surgery, Choledocholithiasis, Gallstones, Surgical aspects, Cholelithiasis, Surgery, Cholecystolithiasis, Gallbladder Disease, Gall Bladder Disorders, gallbladder stones, surgical procedures, surgical treatment, surgeries, surgical procedure
Treatment Papillary ballon dilatation
Clinical Study IdentifierNCT04737642
SponsorUniversity Hospital Inselspital, Berne
Last Modified on11 February 2021


Yes No Not Sure

Inclusion Criteria

Informed Consent as documented by signature (Appendix Informed Consent Form)
Patients 18 years of age
Patients with gallbladder stones and known or expected concomitant bile duct stones
Bile duct stones 6mm in size measured by intraoperative cholangiography

Exclusion Criteria

Women who are pregnant
Declined consent
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
Enrolment of the investigator, his/her family members, employees and other dependent persons
Patients with moderate or severe acute cholangitis
Patients with moderate or severe pancreatitis
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