Endoscopic vs Non-endoscopic Drainage for Benign Gallbladder Diseases in High-risk Patients or Patients Desiring Gallbladder Preservation

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic Gallbladder Drainage: Minimally invasive drainage of the gallbladder using endoscopic techniques, which may be followed by elective transoral stone removal.

Percutaneous Gallbladder Drainage: Traditional non-endoscopic, percutaneous transhepatic drainage of the gallbladder, typically involving long-term passive drainage.

Study summary

Common gallbladder conditions like gallstones, polyps, and gallbladder inflammation are typically treated by surgically removing the gallbladder. However, surgery may be too risky for elderly patients or those with severe medical conditions, and some patients strongly prefer to keep their gallbladder.

Newer, less-invasive endoscopic treatments can drain the gallbladder to treat inflammation without surgery. However, after successful drainage, doctors currently do not know whether it is better to leave a stent inside for long-term drainage or to actively remove the gallbladder stones using an endoscope.

This multicenter study will follow patients in a real-world setting to compare these two approaches: the endoscopic treatment group (stone removal after drainage) and the non-endoscopic treatment group (long-term drainage alone). The goal is to evaluate which method is safer and more effective over the long term, helping doctors make better clinical decisions and improve patients' quality of life.

Eligibility

Primary outcome measure(s)

• Incidence of Overall Adverse Events — Up to 1 year after the initial drainage procedure
  Adverse events related to the drainage procedure and subsequent treatments, including but not limited to bleeding, infection, bile leak, pancreatitis, and stent-related complications.

Trial sites (1)

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