Optimal Handling of Common Bile Duct Calculus, a Prospective Study

NCT ID: NCT01708109

Last Updated: 2019-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-27

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholelithiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Biliary calculus remain

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

Group Type EXPERIMENTAL

no measures taken to clear bile ductus

Intervention Type OTHER

biliary calculus remain

Biliary calculus removed

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

Group Type EXPERIMENTAL

clearance of bile ductus

Intervention Type PROCEDURE

biliary calculus removed at surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no measures taken to clear bile ductus

biliary calculus remain

Intervention Type OTHER

clearance of bile ductus

biliary calculus removed at surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska University Hospital

OTHER

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role collaborator

Sodertalje Hospital

OTHER

Sponsor Role collaborator

Mora Hospital

UNKNOWN

Sponsor Role collaborator

Regional Hopspital Ryhov, Jönköping

UNKNOWN

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Vrinnevi Hospital, Norrköping

UNKNOWN

Sponsor Role collaborator

Sundsvalls Hospital

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anders Thorell

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anders Thorell, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Regional Hospital Ryhov

Jönköping, , Sweden

Site Status

Linköping University Hospital

Linköping, , Sweden

Site Status

Mora Hospital

Mora, , Sweden

Site Status

Vrinnevi Hospital Norrköping

Norrköping, , Sweden

Site Status

Södertälje Hospital

Södertälje, , Sweden

Site Status

Ersta sjukhus

Stockholm, , Sweden

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

Danderyds Hospital

Stockholm, , Sweden

Site Status

Sundsvalls Hospital

Sundsvall, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2011/873-31/3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.