Status:
UNKNOWN
preGallstep - A Clinical Pilot Trial
Lead Sponsor:
Lars Tue Sorensen
Collaborating Sponsors:
Copenhagen Trial Unit, Center for Clinical Intervention Research
Conditions:
Pancreatitis
Cholangitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including...
Detailed Description
Purpose The preGallstep pilot trial is a pilot randomised clinical trial investigating two different surgical methods in patients with common bile duct stones: one-step laparoscopic cholecystectomy wi...
Eligibility Criteria
Inclusion
- Common bile duct stones identified by magnetic resonance cholangiopancreatography (MRCP).
- Age 18 years or older.
- Both interventions must be possible to perform within a clinically reasonable timeframe, as assessed by the investigator.
- Informed consent.
Exclusion
- Patients with acute cholangitis corresponding to a grade III (elevated serum bilirubin, fever, and/or elevated white blood cell count and signs of severe organ failure) according to Tokyo guidelines 2018 including severe organ failure.
- Common bile duct cysts shown by magnetic resonance cholangiopancreatography (MRCP), ultrasonography, computer tomography (CT), or cholangiography.
- Pancreatic/biliary/hepatic malignancies.
- Prior cholecystectomy or sphincterotomy.
- Chronic pancreatitis.
- If assessed by investigator that laparoscopic cholecystectomy is not possible, e.g. due to prior surgery or patient condition.
- Gastric bypass.
- Pregnancy confirmed by elevated choriogonadotropin (hCG) in women below 60 years.
- No informed consent.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04801238
Start Date
April 1 2021
End Date
March 1 2024
Last Update
August 16 2023
Active Locations (1)
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1
Digestive disease center, Bispebjerg Hospital
Copenhagen NV, Not in US/Canada, Denmark, 2400