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.
Age ≥ 18 years, and voluntarily signed the informed consent form;
High-risk surgical patients: ASA classification ≥ III, or presence of severe comorbidities that significantly increase the risk of laparoscopic cholecystectomy (LC);
Patients with concomitant common bile duct stones (CBDS) and a strong desire for gallbladder preservation: presence of CBDS confirmed by MRCP/ERCP examination, and still strongly requesting the preservation of gallbladder function after being fully informed.
Suspected or confirmed gallbladder malignancy;
Complications requiring emergency surgical intervention (gangrene, perforation, diffuse peritonitis);
Uncorrectable severe coagulation dysfunction;
Presence of severe anatomical deformity or obstruction of the stomach, duodenum, or esophagus, where the endoscope is expected to be unable to reach the target site (papilla or pericholecystic area);
high-risk acute cholecystitis patients ineligible for surgery, or patients with benign gallbladder diseases who have a strong preference and clinical requirement for gallbladder-preserving therapy
Cohort
Prospective
Endoscopic Gallbladder Drainage
Procedure/SurgeryMinimally invasive drainage of the gallbladder using endoscopic techniques, which may be followed by elective transoral stone removal.
Percutaneous Gallbladder Drainage
Procedure/SurgeryTraditional non-endoscopic, percutaneous transhepatic drainage of the gallbladder, typically involving long-term passive drainage.
Incidence of Overall Adverse Events
Adverse events related to the drainage procedure and subsequent treatments, including but not limited to bleeding, infection, bile leak, pancreatitis, and stent-related complications.
Rate of technical success for EUS-GBD
The percentage of participants who achieve successful endoscopic ultrasound-guided gallbladder drainage (EUS-GBD). Technical success is defined as successful placement of a lumen-apposing metal stent (LAMS) in the gallbladder, achieving effective gallbladder drainage via a transmural approach.
Rate of technical success for PT-GBD
The percentage of participants who achieve successful percutaneous transhepatic gallbladder drainage (PT-GBD). Technical success is defined as successful placement and establishment of an effective external drainage.
Rate of technical success for ETGBD
The percentage of participants who achieve successful endoscopic transpapillary gallbladder drainage (ETGBD). Technical success is defined as successful crossing of the anatomical barriers of the papilla and the cystic duct, and successful placement of an endoscopic nasogallbladder drainage (ENGBD) tube or an endoscopic gallbladder stent (EGBS) within the gallbladder.
Clinical success
Clinical success is defined as symptom resolution within 3 days (72 hours) after surgery, characterized by defervescence and improved abdominal pain, along with improvement in inflammatory markers including a white blood cell count of \< 10 × 10\^9/L and a continuous downward trend in C-reactive protein (CRP) levels synchronous with clinical improvement.
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