Optimal Handling of Common Bile Duct Calculus, a Prospective Study
This study is currently recruiting participants.
Verified October 2012 by Karolinska Institutet
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
Information provided by (Responsible Party):
Anders Thorell, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01708109
First received: October 9, 2012
Last updated: October 15, 2012
Last verified: October 2012
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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 outcom 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:
Further study details as provided by Karolinska Institutet:
Primary Outcome Measures:
- Natural process of bilary calculus left after cholesystecthomy [ 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 cholecystecthomy, randomized to either remain or removed
Secondary Outcome Measures:
- Complications bilary 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 cholecystecthomy, randomized to either remain or removed
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Bilary calculus remain
bilary calculus, less than or equal to 6 mm
|
Other: no measures taken to clear bile ductus
bilary calculus remain
|
|
Active Comparator: Bilary calculus removed
bilary calculus, less than or equal to 6 mm
|
Procedure: clearance of bile ductus
bilary calculus removed at surgery
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cholesystecthomy
Exclusion Criteria:
- Ongoing icterus or pancreatitis
- History of anamnes pancreatit/icterus
- Allergy against x-ray contrast
- Stones more than 6 mm in ductus
- No passage of contrast to duodenum
- malignant
Contacts and Locations
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
No publications provided
| 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: | October 15, 2012 |
| 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 May 19, 2013