preGallstep - A Clinical Pilot Trial

Launched by LARS TUE SORENSEN · Mar 15, 2021

Keywords

ClinConnect Summary

The preGallstep trial is studying two different ways to treat patients with common bile duct stones, which can cause conditions like pancreatitis and jaundice. In Denmark, many people undergo surgery each year to remove their gallbladders, and some also need treatment for these stones. Traditionally, a two-step approach is used, but this trial is exploring a potentially safer one-step method that combines both treatments in one surgery. The goal is to see if this new approach leads to fewer complications and shorter hospital stays.

To be part of this trial, participants must be adults over 18 years old and have confirmed common bile duct stones. They cannot have certain serious conditions, like severe infections or specific previous surgeries. If someone joins the trial, they will be randomly assigned to either the new one-step method or the traditional two-step method. The trial will monitor patients for 90 days after their procedure to check for any serious complications. This research aims to improve treatment options for hundreds of patients in Denmark each year.

Gender

ALL

Eligibility 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.