Optimal Handling of Common Bile Duct Calculus, a Prospective Study

Karolinska Institute

Status: Terminated

Conditions: Cholelithiasis

Treatments: Procedure: clearance of bile ductus; Other: no measures taken to clear bile ductus

Study type: Interventional

Funder types: Other

Identifiers

NCT01708109

2011/873-31/3

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Biliary calculus remain

Experimental group

Description:

biliary calculus, less than or equal to 6 mm, remains

Treatment:

Other: no measures taken to clear bile ductus

Biliary calculus removed

Experimental group

Description:

biliary calculus, less than or equal to 6 mm, removed

Treatment:

Procedure: clearance of bile ductus