Efficacy and Safety Evaluation of Endoscopic Treatment for Benign Gallbladder Diseases: A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Incidence of Overall Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
排除标准
- •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);
- •Significant gallbladder atrophy (longitudinal diameter < 4 cm or anteroposterior diameter < 2 cm);
- •Pregnant or lactating women;
- •Previous history of cholecystectomy;
- •Presence of psychiatric disorders or any condition that prevents cooperation with treatment and follow-up;
- •Unwilling or unable to sign the informed consent form.
研究组 & 干预措施
Endoscopic Treatment Group
干预措施: Endoscopic Gallbladder Drainage (Procedure)
Non-endoscopic Treatment Group
干预措施: Percutaneous Gallbladder Drainage (Procedure)
结局指标
主要结局
Incidence of Overall Adverse Events
时间窗: 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.
次要结局
- Rate of technical success for EUS-GBD(During the procedure)
- Rate of technical success for PT-GBD(During the procedure)
- Rate of technical success for ETGBD(During the procedure)
- Clinical success(Within 3 days (72 hours) postoperatively)
- Unplanned re-interventions within 1 year postoperatively(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(6 months postoperatively, and 1 year postoperatively)
- Change in Gastrointestinal Quality of Life Index (GIQLI) Total Score(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)
研究者
Yanglin Pan
Professor
Air Force Military Medical University, China
