Scheduled Stent Removal vs Observation in Patients Undergoing EUS-guided Gallbladder Drainage. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Recurrence of GB findings
研究概览
简要总结
The study will compare the outcomes of patients with gallstone related cholecystitis who are poor surgical candidates undergoing EUS guided cholecystoenterostomy via a lumen apposing metal stent (LAMS).
详细描述
The study will include patients with stone related cholecystitis that are not adequate surgical candidates that will be treated with EUS guided cholecystoenterostomy with endoscopic stone extraction. Patients will be randomized to stent removal immediately after gallstones have been removed or to observation for 1 year with the stent in place. Outcomes to be measured include recurrence of stone disease and rate of complications from the procedure in both groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-100 years or age
- •Both genders
- •Diagnosis of acute cholecystitis by TG13 criteria.
- •Patients who are able to give consent
- •Patients who are deemed poor surgical candidates for cholecystectomy by the surgical/medical team.
排除标准
- •Unable to provide informed consent
- •Cardiorespiratory dysfunction that precludes sedation
- •Pregnant females
- •Presence of ascites (distance between duodenum and GB > 1 cm) and/or coagulopathy (INR > 3, PLT <20K)
研究组 & 干预措施
Scheduled removal
This group involves patients who will have the LAMS removed immediately after all the stones have been cleared from the gallbladder
干预措施: Stent removal (Procedure)
Observation
This group involves patients who will be followed closely for 1 year after all the stones have been removed from the gallbladder. These patients will keep the stent in place for 1 year and at that time the patients will be offered removal of the stent.
干预措施: Stent removal (Procedure)
结局指标
主要结局
Recurrence of GB findings
时间窗: 1 year
To compare the recurrence of GB findings in patients undergoing EUS guided GB drainage with a lumen-apposing metal stent(LAMS) assigned to scheduled stent removal vs those assigned to long-term observation only.
次要结局
- Rate of adverse events related to LAMS(1 year)
研究者
Antonio Mendoza-Ladd
Assistant Professor of Medicine/Director of Endoscopy
Texas Tech University Health Sciences Center, El Paso