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TerminatedNCT01708109Updated Mar 1, 2019

Optimal Handling of Common Bile Duct Calculus, a Prospective Study

An interventional study of no measures taken to clear bile ductus and clearance of bile ductus in Cholelithiasis, sponsored by Karolinska Institutet. Terminated at 9 sites in Sweden. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-01.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Why this study was terminated
Lack of recruting patients to the study

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Nov 2011, registered Oct 2012).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Cholelithiasis

286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.

This study's enrollment of 35 is below the median of 90 across 197 interventional studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • cholecystectomy

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Biliary calculus remain

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

    Other: no measures taken to clear bile ductus

  • Experimental
    Biliary calculus removed

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

    Procedure: clearance of bile ductus

Interventions

  • Otherno measures taken to clear bile ductus

    biliary calculus remain

  • Procedureclearance of bile ductus

    biliary calculus removed at surgery

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 month post op

Secondary outcomes

  1. Complications biliary calculus

    Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed

    Time frame: 12 month post op

07

Study locations

9 sites
  • Regional Hospital Ryhov
    Jönköping, SE-, Sweden
  • Linköping University Hospital
    Linköping, SE-581 85, Sweden
  • Mora Hospital
    Mora, SE-792 85, Sweden
  • Vrinnevi Hospital Norrköping
    Norrköping, SE-, Sweden
  • Ersta sjukhus
    Stockholm, 116 91, Sweden
  • Karolinska University Hospital
    Stockholm, SE-141 86, Sweden
  • Danderyds Hospital
    Stockholm, SE-182 88, Sweden
  • Sundsvalls Hospital
    Sundsvall, SE-, Sweden
  • Södertälje Hospital
    Södertälje, SE-, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01708109
Lead sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital, Danderyd Hospital, Sodertalje Hospital, Mora Hospital, Regional Hopspital Ryhov, Jönköping, University Hospital, Linkoeping, Vrinnevi Hospital, Norrköping, Sundsvalls Hospital
Responsible party
Anders Thorell (Ass. Prof., Karolinska Institutet) — Principal investigator
First posted
Oct 16, 2012
Start date
Nov 27, 2011
Primary completion
Nov 20, 2017
Completion
Jan 2018
Last update
Mar 1, 2019

Study contacts

Anders Thorell, Assoc Prof
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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