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Optimal Handling of Common Bile Duct Calculus, a Prospective Study

Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01708109
Enrollment
35
Registered
2012-10-16
Start date
2011-11-27
Completion date
2018-01-31
Last updated
2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis

Brief summary

The purpose is to study natural process of gallstones in common bile duct, stones less than or equal to 6 mm. And if the gallstones give any complications under 1 year follow up. The second outcome is to study side-effects of gallstones removed with surgery.

Interventions

OTHERno measures taken to clear bile ductus

biliary calculus remain

PROCEDUREclearance of bile ductus

biliary calculus removed at surgery

Sponsors

Karolinska University Hospital
CollaboratorOTHER
Danderyd Hospital
CollaboratorOTHER
Sodertalje Hospital
CollaboratorOTHER
Mora Hospital
CollaboratorUNKNOWN
Regional Hopspital Ryhov, Jönköping
CollaboratorUNKNOWN
University Hospital, Linkoeping
CollaboratorOTHER
Vrinnevi Hospital, Norrköping
CollaboratorUNKNOWN
Sundsvalls Hospital
CollaboratorUNKNOWN
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* cholecystectomy

Exclusion criteria

* Ongoing icterus or pancreatitis * History of anamneses pancreatitis/icterus * Allergy against x-ray contrast * Stones more than 6 mm in ductus * No passage of contrast to duodenum * malignant

Design outcomes

Primary

MeasureTime frameDescription
Natural process of biliary calculus left after cholecystectomy12 month post opCalculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed

Secondary

MeasureTime frameDescription
Complications biliary calculus12 month post opCalculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026