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

Benign gallbladder diseases, such as symptomatic cholelithiasis, gallbladder polyps, and acute cholecystitis, are common in clinical practice. Although laparoscopic cholecystectomy (LC) remains the gold standard treatment, its application is limited in elderly patients, individuals with severe comorbidities, or specific populations who strongly desire to preserve gallbladder function (termed "high-risk" or specific-preference patients).

In recent years, endoscopic gallbladder drainage techniques characterized by ultra-minimally invasive approaches-such as endoscopic transpapillary gallbladder drainage (ET-GBD) and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD)-have advanced rapidly. These techniques not only provide a critical, life-saving means for patients unable to undergo surgery during the acute phase, but also elevate the therapeutic goal from simple "drainage for inflammation control" to a new height of "long-term disease management" and "organ function preservation." However, following successful drainage, whether to opt for long-term passive drainage via indwelling stents or to actively pursue endoscopic stone removal for a potential "cure" currently lacks guidance from high-level clinical evidence.

Therefore, conducting a large-scale, multicenter, prospective cohort study to evaluate and compare endoscopic treatments for gallbladder diseases holds significant theoretical and practical value. First, at the clinical practice level, this prospective study aims to systematically compare the long-term efficacy and safety between the "endoscopic treatment group" (elective transoral stone removal after drainage) and the "non-endoscopic treatment group" (long-term passive drainage alone). This will provide direct evidence to resolve the core clinical conflict between "gallbladder preservation" and "disease recurrence," driving the treatment paradigm shift from a technical capability-oriented approach to a precise patient benefit-oriented one. Second, at the academic level, this study will be the first to clarify the impact of endoscopic interventions on patients' long-term gallbladder function, quality of life, and subsequent clinical pathways within a large-scale cohort, thereby filling a critical evidence gap in this field. Finally, at the health policy level, the study findings will provide a core foundation for establishing individualized and standardized clinical guidelines, optimizing medical resource allocation, and ultimately improving the overall prognosis and quality of life for patients with complex gallbladder diseases.

• Rate of technical success for EUS-GBD [Срок оценки: During the procedure]
• Rate of technical success for PT-GBD [Срок оценки: During the procedure]
• Rate of technical success for ETGBD [Срок оценки: During the procedure]
• Clinical success [Срок оценки: Within 3 days (72 hours) postoperatively]
• Unplanned re-interventions within 1 year postoperatively [Срок оценки: At 72 hours, 14 days, 30 days, 90 days, 6 months, and 1 year postoperatively]
• Early adverse events [Срок оценки: 14 days postoperatively]
• Late adverse events [Срок оценки: 30 days, 90 days, 6 months, and 1 year postoperatively]
• Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score [Срок оценки: 6 months postoperatively, and 1 year postoperatively]
• Change in Gastrointestinal Quality of Life Index (GIQLI) Total Score [Срок оценки: 6 months postoperatively, and 1 year postoperatively]
• Total length of hospital stay [Срок оценки: From date of admission through date of discharge, up to 30 day]
• Total cost of hospitalization [Срок оценки: Through discharge, up to 30 days]