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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Treatment Group |
| ||
| Non-endoscopic Treatment Group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Gallbladder Drainage | Procedure | Minimally invasive drainage of the gallbladder using endoscopic techniques, which may be followed by elective transoral stone removal. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year after the initial drainage procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the procedure |
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Inclusion Criteria:
Age ≥ 18 years, and voluntarily signed the informed consent form;
Radiologically confirmed symptomatic benign gallbladder disease (symptomatic gallbladder stones, gallbladder polyps meeting surgical indications, acute cholecystitis TG18 Grade I/II); and meeting any of the following specific population criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanglin Pan | Contact | +86 13991811225 | yanglinpan@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | 710000 | China |
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| Percutaneous Gallbladder Drainage | Procedure | Traditional non-endoscopic, percutaneous transhepatic drainage of the gallbladder, typically involving long-term passive drainage. |
|
| 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. | During the procedure |
| 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. | During the procedure |
| 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. | Within 3 days (72 hours) postoperatively |
| Unplanned re-interventions within 1 year postoperatively | Through postoperative inpatient observation and post-discharge telephone follow-ups, the investigators will monitor and record whether patients require any additional, unplanned secondary invasive procedures (including endoscopic therapy, interventional radiologic puncture, or surgery) following successful initial gallbladder drainage (such as EUS-GBD, PT-GBD/PTGBD, or ETGBD) or surgical treatment, resulting from unexpected clinical deterioration, drainage device malfunction/failure, or treatment-related complications. | At 72 hours, 14 days, 30 days, 90 days, 6 months, and 1 year postoperatively |
| Early adverse events | 14 days postoperatively |
| Late adverse events | 30 days, 90 days, 6 months, and 1 year postoperatively |
| Change in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score | The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L index score ranges from values below 0 (health states worse than death) to 1.0 (perfect health). Higher scores indicate better health-related quality of life. | 6 months postoperatively, and 1 year postoperatively |
| Change in Gastrointestinal Quality of Life Index (GIQLI) Total Score | The Gastrointestinal Quality of Life Index (GIQLI) is a validated questionnaire assessing gastrointestinal symptoms, physical status, emotional status, social function, and treatment effects. Total scores range from 0 to 144, with higher scores indicating better gastrointestinal quality of life. | 6 months postoperatively, and 1 year postoperatively |
| Total length of hospital stay | From date of admission through date of discharge, up to 30 day |
| Total cost of hospitalization | Through discharge, up to 30 days |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D041881 | Cholecystitis, Acute |
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002764 | Cholecystitis |
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