Optimal Handling of Common Bile Duct Calculus, a Prospective Study

Not Applicable

Terminated

• Conditions: Cholelithiasis
• Interventions: Other: no measures taken to clear bile ductus; Procedure: clearance of bile ductus

• Registration Number: NCT01708109
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-27
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Primary Completion: 2017-11-20
• Study Completion: 2018-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biliary calculus remain	no measures taken to clear bile ductus	biliary calculus, less than or equal to 6 mm, remains
Biliary calculus removed	clearance of bile ductus	biliary calculus, less than or equal to 6 mm, removed

Primary Outcome Measures

Name	Time	Method
Natural process of biliary calculus left after cholecystectomy	12 month post op	Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed

Secondary Outcome Measures

Name	Time	Method
Complications biliary calculus	12 month post op	Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed

Trial Locations

Locations (9)

Mora Hospital; 🇸🇪 Mora, Sweden

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Regional Hospital Ryhov; 🇸🇪 Jönköping, Sweden

Vrinnevi Hospital Norrköping; 🇸🇪 Norrköping, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Ersta sjukhus; 🇸🇪 Stockholm, Sweden

Danderyds Hospital; 🇸🇪 Stockholm, Sweden

Södertälje Hospital; 🇸🇪 Södertälje, Sweden

Sundsvalls Hospital; 🇸🇪 Sundsvall, Sweden