Status:
COMPLETED
Feasibility and Safety of Bile Duct Clearance by Transcystic Sphincter of Oddi Balloon Dilatation
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Cholecystolithiasis
Choledocholithiasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 (c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2022
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04737642
Start Date
January 4 2021
End Date
October 9 2022
Last Update
January 26 2023
Active Locations (1)
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1
Inselspital Bern (Department for Visceral Surgery and Medicine)
Bern, Switzerland, 3010