One-step surgery for common bile duct stones
preGallstep: One-step Laparoscopic Cholecystectomy, Common Bile Duct Exploration and Stone Extraction Versus Two-step Endoscopic Retrograde Cholangiography and Stone Extraction Plus Laparoscopic Cholecystectomy for Common Bile Duct Stones
NA · Bispebjerg Hospital · NCT04801238
This study is testing whether a one-step surgery for common bile duct stones is safer and more effective than the usual two-step approach for patients needing treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bispebjerg Hospital (other) |
| Locations | 1 site (Copenhagen NV, Not In US/Canada) |
| Trial ID | NCT04801238 on ClinicalTrials.gov |
What this trial studies
The preGallstep trial is a multicenter randomized clinical pilot trial that compares two surgical methods for treating common bile duct stones: a one-step laparoscopic cholecystectomy with common bile duct exploration versus a conventional two-step approach involving endoscopic retrograde cholangiography followed by laparoscopic cholecystectomy. The trial aims to evaluate patient safety and the number of procedures required for stone clearance. By assessing complications in the control group, the study seeks to provide data for a larger confirmatory trial in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with common bile duct stones identified by imaging techniques.
Not a fit: Patients with acute cholangitis, pancreatic/biliary malignancies, or those who have had prior surgeries that complicate laparoscopic cholecystectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could lead to a safer and more efficient surgical approach for patients with common bile duct stones.
How similar studies have performed: Previous studies have suggested that a one-step approach may be superior, but more data is needed, making this trial a necessary step in exploring this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: 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.
Where this trial is running
Copenhagen NV, Not In US/Canada
- Digestive disease center, Bispebjerg Hospital — Copenhagen NV, Not In US/Canada, Denmark (RECRUITING)
Study contacts
- Study coordinator: Anders Kirkegaard-klitbo, MD
- Email: anders.kirkegaard-Klitbo@regionh.dk
- Phone: +4520713638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pancreatitis, Cholangitis, Cholecystitis, Gallstone, Jaundice, Obstructive, Obstructive Jaundice, gallbladder stones, common bile duct