Optimal Handling of Common Bile Duct Calculus, a Prospective Study

Cholelithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01708109
• Other study ID #: 2011/873-31/3
• Status: Terminated
• Phase: N/A
• Start date: November 27, 2011
• Est. completion date: January 2018

Study information

• Verified date: February 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: January 2018
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Other:
• no measures taken to clear bile ductus
biliary calculus remain

Procedure:
• clearance of bile ductus
biliary calculus removed at surgery

Locations

Country	Name	City	State
Sweden	Regional Hospital Ryhov	Jönköping
Sweden	Linköping University Hospital	Linköping
Sweden	Mora Hospital	Mora
Sweden	Vrinnevi Hospital Norrköping	Norrköping
Sweden	Södertälje Hospital	Södertälje
Sweden	Danderyds Hospital	Stockholm
Sweden	Ersta sjukhus	Stockholm
Sweden	Karolinska University Hospital	Stockholm
Sweden	Sundsvalls Hospital	Sundsvall

Sponsors (9)

Lead Sponsor	Collaborator
Karolinska Institutet	Danderyd Hospital, Karolinska University Hospital, Mora Hospital, Regional Hopspital Ryhov, Jönköping, Sodertalje Hospital, Sundsvalls Hospital, University Hospital, Linkoeping, Vrinnevi Hospital, Norrköping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural process of biliary calculus left after cholecystectomy	Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed	12 month post op
Secondary	Complications biliary calculus	Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed	12 month post op