Optimal Handling of Common Bile Duct Calculus, a Prospective Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Cholelithiasis
• Intervention / Treatment: Other: no measures taken to clear bile ductus; Procedure: clearance of bile ductus

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Jönköping, Sweden, SE-
    • Regional Hospital Ryhov
  • Linköping, Sweden, SE-581 85
    • Linköping University Hospital
  • Mora, Sweden, SE-792 85
    • Mora Hospital
  • Norrköping, Sweden, SE-
    • Vrinnevi Hospital Norrköping
  • Stockholm, Sweden, 116 91
    • Ersta sjukhus
  • Stockholm, Sweden, SE-141 86
    • Karolinska university hospital
  • Stockholm, Sweden, SE-182 88
    • Danderyds Hospital
  • Sundsvall, Sweden, SE-
    • Sundsvalls hospital
  • Södertälje, Sweden, SE-
    • Södertälje Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biliary calculus remain; biliary calculus, less than or equal to 6 mm, remains	Other: no measures taken to clear bile ductus; biliary calculus remain
Experimental: Biliary calculus removed; biliary calculus, less than or equal to 6 mm, removed	Procedure: clearance of bile ductus; biliary calculus removed at surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; University Hospital, Linkoeping; Danderyd Hospital; Sodertalje Hospital; Mora Hospital; Regional Hopspital Ryhov, Jönköping; Vrinnevi Hospital, Norrköping; Sundsvalls Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2011
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: October 9, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 2011/873-31/3