Gallstone DiseaseRIBONCT02351492
Radiological Investigation of Bile Duct Obstruction
A study testing Cholecystectomy and intraoperative cholangiography, Magnet resonance cholangio-pancreaticography and magnet resonance imaging in people with Gallstone Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Patients with gallstone disease should be checked whether a common bile duct (CBD) stone could be present. In case of a certain suspicion for CBD stones further investigations should be performed. This can either be done by magnetic resonance cholangio-pancreaticography (MRCP) or by intraoperative cholangiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallstone Disease
- What is being tested?
- Cholecystectomy and intraoperative cholangiography, Magnet resonance cholangio-pancreaticography and magnet resonance imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting as regular admission or at the emergency department (ED) with cholecystolithiasis and suspected CBD stones. The indication for CBD investigation requires one of the following features:
- Elevated bilirubin ii. ASAT/ALAT or gGT or aP above the normal range (two of them) iii. Choledocholithiasis in ultrasound iv. Dilated bile ducts in ultrasound
- Written informed consent
Who cannot join
- Age under 18 years
- Patients with biliary pancreatitis (due to the fact that conservative treatment is initiated before gallbladder removal and therefore leads to a prolonged hospital stay)
- Septic patients due to cholangitis
- Patients unable to consent
- Patients with medical conditions preventing surgery
- Pregnancy
- Radiologically proven CBD stone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Pathway for Surgical Patients With Suspected Bile Duct Obstruction
Patients with gallstone disease should be checked whether a common bile duct (CBD) stone could be present. In case of a certain suspicion for CBD stones further investigations should be performed. This can either be done by magnetic resonance cholangio-pancreaticography (MRCP) or by intraoperative cholangiography. The study investigates which pathway would be favorable in regard of an early hospital demission.
Read the detailed description
Patients with gallstone disease and suspected bile duct obstruction can be investigated either with a magnetic resonance cholangio-pancreaticography (MRCP) prior to gallbladder removal or with an intraoperative cholangiography during cholecystectomy. When detecting an common bile duct (CBD) stone in MRCP, normally endoscopic removal is performed before an operation. When the CBD stone is detected during gallbladder removal instead, endoscopic retrograde cannulation of the pancreatic duct (ERCP) will follow after the operation. Investigators hypothesize that direct operation shortens the length of hospital stay. Therefore investigators randomize patients with elevated Bilirubin, elevated liver enzymes (two of the following: aspartate transaminase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (gGT) or AP), suspected CBD stones in ultrasound or dilated common bile ducts either in MRCP first or operation first pathway. All data (patient admission to discharge, ...) will be entered in an online database
- Conditions
- Gallstone Disease
- Being tested
- Cholecystectomy and intraoperative cholangiography, Magnet resonance cholangio-pancreaticography, magnet resonance imaging, catheter
- Keywords
- Bile duct obstruction, intraoperative cholangiography, MRCP
- Medical subject headings
- Cholelithiasis, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecystectomy and intraoperative cholangiographyProcedure or surgery
Also called IOC
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
Magnet resonance cholangio-pancreaticographyProcedure or surgery
Also called MRCP
Patients get Magnet resonance cholangio-pancreaticography MRCP first. In case of detected gallstones, removal of the stones by endoscopic retrograde cholangiopancreaticography will be performed before gallbladder removal.
magnet resonance imagingDevice
Also called MRI
Patients get Magnet resonance cholangio-pancreaticography MRCP first. In case of detected gallstones, removal of the stones by endoscopic retrograde cholangiopancreaticography will be performed before gallbladder removal.
catheterDevice
Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
| Study group | Role | What they receive |
|---|---|---|
| Cholecystectomy and intraoperative cholangiography | Active comparator | Patients with suspected bile duct obstruction intraoperative cholangiography (IOC) to investigate bile ducts. Receives: Procedure: Cholecystectomy and intraoperative cholangiography; Device: catheter |
| Magnet resonance cholangio-pancreaticography | Active comparator | Patients get Magnet resonance cholangio-pancreaticography (MRCP) first. In case of detected gallstones, removal of the stones by endoscopic retrograde cholangiopancreaticography will be performed before gallbladder removal. Receives: Procedure: Magnet resonance cholangio-pancreaticography; Device: magnet resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital stay
Time of hospital entry to time of patient dischargeable, according to stuff surgeon. Dates will be entered in an online database, which is also used for randomisation.
Measured: number of days patient spent in hospital assessed at discharge day, on average 8 days
Secondary outcomes (1)
Costs of Hospital stay
Computed by the financial departments of each involved hospital
Measured: days in hospital assessed at hospital discharge day, on average 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2021
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gallstone DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Christian A. Nebiker, MD, PD Dr., Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351492
- Sponsor's protocol ID
- 221/13
- Acronym
- RIBO
- Status last verified
- Dec 2022
- First submitted
- 7 Jan 2015
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Staubli SM, Kettelhack C, Oertli D, von Holzen U, Zingg U, Mattiello D, Rosenberg R, Mechera R, Rosenblum I, Pfefferkorn U, Kollmar O, Nebiker CA. Efficacy of intraoperative cholangiography versus preoperative magnetic resonance cholangiography in patients with intermediate risk for common bile duct stones. HPB (Oxford). 2022 Nov;24(11):1898-1906. doi: 10.1016/j.hpb.2022.05.1346. Epub 2022 Jun 18.
PubMed 35817694
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Pathway for Surgical Patients With Suspected Bile Duct Obstruction
- ClinicalTrials.gov ID
- NCT02351492
- Acronym / sponsor ID
- RIBO / 221/13
- Conditions
- Gallstone Disease
- Keywords
- Bile duct obstruction, intraoperative cholangiography, MRCP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- May 2015
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with gallstone disease should be checked whether a common bile duct (CBD) stone could be present. In case of a certain suspicion for CBD stones further investigations should be performed. This can either be done by magnetic resonance cholangio-pancreaticography (MRCP) or by intraoperative cholangiography. The study investigates which pathway would be favorable in regard of an early hospital demission.
Detailed description
Patients with gallstone disease and suspected bile duct obstruction can be investigated either with a magnetic resonance cholangio-pancreaticography (MRCP) prior to gallbladder removal or with an intraoperative cholangiography during cholecystectomy. When detecting an common bile duct (CBD) stone in MRCP, normally endoscopic removal is performed before an operation. When the CBD stone is detected during gallbladder removal instead, endoscopic retrograde cannulation of the pancreatic duct (ERCP) will follow after the operation. Investigators hypothesize that direct operation shortens the length of hospital stay. Therefore investigators randomize patients with elevated Bilirubin, elevated liver enzymes (two of the following: aspartate transaminase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyltransferase (gGT) or AP), suspected CBD stones in ultrasound or dilated common bile ducts either in MRCP first or operation first pathway. All data (patient admission to discharge, ...) will be entered in an online database
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecystectomy and intraoperative cholangiography | Active comparator | Procedure: Cholecystectomy and intraoperative cholangiography, Device: catheterPatients with suspected bile duct obstruction intraoperative cholangiography (IOC) to investigate bile ducts. |
| Magnet resonance cholangio-pancreaticography | Active comparator | Procedure: Magnet resonance cholangio-pancreaticography, Device: magnet resonance imagingPatients get Magnet resonance cholangio-pancreaticography (MRCP) first. In case of detected gallstones, removal of the stones by endoscopic retrograde cholangiopancreaticography will be performed before gallbladder removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting as regular admission or at the emergency department (ED) with cholecystolithiasis and suspected CBD stones. The indication for CBD investigation requires one of the following features:
- Written informed consent
Key exclusion criteria (7 listed)
- Age under 18 years
- Patients with biliary pancreatitis (due to the fact that conservative treatment is initiated before gallbladder removal and therefore leads to a prolonged hospital stay)
- Septic patients due to cholangitis
- Patients unable to consent
- Patients with medical conditions preventing surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecystectomy and intraoperative cholangiographyAlso: IOCPatients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts. | Procedure or surgery | Cholecystectomy and intraoperative cholangiography |
| Magnet resonance cholangio-pancreaticographyAlso: MRCPPatients get Magnet resonance cholangio-pancreaticography MRCP first. In case of detected gallstones, removal of the stones by endoscopic retrograde cholangiopancreaticography will be performed before gallbladder removal. | Procedure or surgery | Magnet resonance cholangio-pancreaticography |
| magnet resonance imagingAlso: MRIPatients get Magnet resonance cholangio-pancreaticography MRCP first. In case of detected gallstones, removal of the stones by endoscopic retrograde cholangiopancreaticography will be performed before gallbladder removal. | Device | Magnet resonance cholangio-pancreaticography |
| catheterPatients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts. | Device | Cholecystectomy and intraoperative cholangiography |
Primary outcome
Length of Hospital stay
Time frame: number of days patient spent in hospital assessed at discharge day, on average 8 days
Time of hospital entry to time of patient dischargeable, according to stuff surgeon. Dates will be entered in an online database, which is also used for randomisation.
1 secondary outcome
Costs of Hospital stay
Time frame: days in hospital assessed at hospital discharge day, on average 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Background: PubMed 35817694Staubli SM, Kettelhack C, Oertli D, von Holzen U, Zingg U, Mattiello D, Rosenberg R, Mechera R, Rosenblum I, Pfefferkorn U, Kollmar O, Nebiker CA. Efficacy of intraoperative cholangiography versus preoperative magnetic resonance cholangiography in patients with intermediate risk for common bile duct stones. HPB (Oxford). 2022 Nov;24(11):1898-1906. doi: 10.1016/j.hpb.2022.05.1346. Epub 2022 Jun 18.
Related trials for Gallstone Disease
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian A. Nebiker, MD, PD Dr. principal investigator
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecystectomy and intraoperative cholangiography, Magnet resonance cholangio-pancreaticography and magnet resonance imaging in people with Gallstone Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital stay (time frame: number of days patient spent in hospital assessed at discharge day, on average 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02351492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.