Optimal Handling of Common Bile Duct Calculus, a Prospective Study

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2016 by Karolinska Institutet

Sponsor:

Collaborators:

Karolinska University Hospital

Danderyd Hospital

Sodertalje Hospital

Mora Hospital

Regional Hopspital Ryhov, Jönköping

University Hospital, Linkoeping

Vrinnevi Hospital, Norrköping

Sundsvalls Hospital

Information provided by (Responsible Party):

Anders Thorell, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT01708109

First received: October 9, 2012

Last updated: August 31, 2016

Last verified: August 2016

History of Changes

Purpose

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.

Condition	Intervention
Cholelithiasis	Other: no measures taken to clear bile ductus Procedure: clearance of bile ductus


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Optimal Handling of Common Bile Duct Calculus, a Prospective Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Gallstones

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:

Natural process of biliary calculus left after cholecystectomy [ Time Frame: 12 month post op ] [ Designated as safety issue: Yes ]
Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed

Secondary Outcome Measures:

Complications biliary calculus [ Time Frame: 12 month post op ] [ Designated as safety issue: Yes ]
Calculus in common bile duct less than or equal to 6 mm found during cholecystectomy, randomized to either remain or removed


Estimated Enrollment:	200
Study Start Date:	November 2011
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708109

Contacts


Contact: Mats Möller, MD	+46 (0) 8 7146201 ext 6201	mats.moller@erstadiakoni.se
Contact: Anders Thorell, Ass. Prof.	+46 (0) 8 71406541 ext 6541	anders.thorell@erstadiakoni.se

Locations


Sweden
Regional Hospital Ryhov	Recruiting
Jönköping, Sweden, SE-
Contact: Erik Svartholm +46 (0) 36-321919 erik.svartholm@lj.se
Sub-Investigator: Erik Svartholm
Linköping University Hospital	Recruiting
Linköping, Sweden, SE-581 85
Contact: Per Sandström per.sandstrom@lio.se
Sub-Investigator: Per Sandstrom
Mora Hospital	Recruiting
Mora, Sweden, SE-792 85
Contact: Johanna Österberg +46(0)250-493321 johanna.osterberg@ltdalarna.se
Sub-Investigator: Johanna Österberg
Vrinnevi Hospital Norrköping	Recruiting
Norrköping, Sweden, SE-
Contact: Kalev Teder kalev.teder@lio.se
Sub-Investigator: Kalev Teder
Ersta sjukhus	Recruiting
Stockholm, Sweden, 116 91
Contact: Mats Möller, MD +46 (0) 8 714 6201 ext 6201 mats.moller@erstadiakoni.se
Contact: Anders Thorell, Ass. Prof. +46 (0) 8 7146541 ext 6541 anders.thorell@erstadiakoni.se
Principal Investigator: Mats Möller, MD
Karolinska University Hospital	Recruiting
Stockholm, Sweden, SE-141 86
Contact: Gabriel Sandblom gabriel.sandblom@ki.se
Sub-Investigator: Gabriel Sandblom
Danderyds Hospital	Recruiting
Stockholm, Sweden, SE-182 88
Contact: Richard Marsk +46 (0) 70-7608310 richard.marsk@ds.se
Sub-Investigator: Richard Marsk
Sundsvalls Hospital	Recruiting
Sundsvall, Sweden, SE-
Contact: Yucel Cengiz yucel.cengiz@lvn.se
Sub-Investigator: Yucel Cengiz
Södertälje Hospital	Recruiting
Södertälje, Sweden, SE-
Contact: Anders Thörne +46(0)8 550 241 67 Anders.thorne@sodertaljesjukhus.se
Sub-Investigator: Anders Thörne

Sponsors and Collaborators

Karolinska Institutet

Karolinska University Hospital

Danderyd Hospital

Sodertalje Hospital

Mora Hospital

Regional Hopspital Ryhov, Jönköping

University Hospital, Linkoeping

Vrinnevi Hospital, Norrköping

Sundsvalls Hospital

Investigators


Principal Investigator:	Anders Thorell, Assoc Prof	Karolinska Institutet

More Information


Responsible Party:	Anders Thorell, Ass. Prof., Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT01708109 History of Changes
Other Study ID Numbers:	2011/873-31/3
Study First Received:	October 9, 2012
Last Updated:	August 31, 2016
Health Authority:	Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:


Calculi Cholelithiasis Cholecystolithiasis Gallstones	Pathological Conditions, Anatomical Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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