Prophylactic Endoscopic Ultrasound Gallbladder Drainage (EUS-GBD) in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Ocurrence of acute cholecystitis
研究概览
简要总结
to determine if primary prophylaxis with Endoscopic Ultrasound-Gallbladder Drainage (EUS-GBD) in unresectable cancer patients with the orifice of the cystic duct (OCD) involvement is superior to conservative management (Non EUS-guided gallbladder drainage).
详细描述
Endoscopic biliary drainage with a self-expandable metal stent (SEMS) is an accepted form of palliative therapy for distal malignant biliary obstruction (MBO); it is a low invasive procedure with a long-term patency.
Covered SEMSs have a longer patency than uncovered SEMSs in patients with MBO, because covered SEMSs can prevent tumor ingrowth. However, complications of covered SEMSs include stent occlusion, migration, kinking, non-occlusion cholangitis, liver abscess, pancreatitis and cholecystitis.
Nonsurgical decompression of the gallbladder is urgently needs to prevent sepsis, perforation and death in patients with acute cholecystitis. Several risk factors of cholecystitis after SEMS placement for distal MBO have been reported: however, tumor involvement to the orifice of the cystic duct (OCD) is the major predictive factor for cholecystitis after endoscopic SEMSs placement for distal MBO palliative treatment .
Acute cholecystitis related to SEMSs deployment was evaluated in 2009, by using endoscopic trans-papillary gallbladder drainage (TPGBD) in 11 individuals in whom SEMSs covered the OCD. None episode of cholecystitis was reported, however TPGBD is a difficult technique with a high rate of stent dislodgement and reintervention needed.
EUS-GBD by using a lumen apposing metal stent have been proposed, but only for acute cholecystitis treatment or symptomatic gallbladder hydrops, never as a prophylactic technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Above 18 years old.
- •Obtained written consent for procedures
- •Unresectable malignant biliary obstruction diagnosed by Endoscopic Ultrasound and confirmed by confocal laser endomicroscopy (CLE) during cholangioscopy and histopathology.
- •Tumor involvement to the orifice of the cystic duct.
- •Self-expandable metallic plastic stent deployment as palliative therapy for distal biliary obstruction.
排除标准
- •Under 18 years old.
- •Refuse to sign written informed consent.
- •Pregnancy
- •Previous cholecystectomy
- •Acute cholecystitis prior enrollment
- •Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.
- •Large vessel between the gallbladder and gastric-duodenal wall.
- •Coagulopathy
- •Intrahepatic cholangiocarcinoma
- •Previous gallbladder drainage by percutaneous or endoscopic techniques.
结局指标
主要结局
Ocurrence of acute cholecystitis
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
• Occurrence of acute cholecystitis according to Tokyo guidelines 2013: Clinical symptoms showing right upper or epigastric pain or tenderness, signs of systematic inflammation (fever, elevated white blood cell count, and C-reactive protein), or positive findings on abdominal ultrasonography (US) or computed tomography (CT).
次要结局
- Clinical success rate:(since enrollment until 30-days follow up.)
- presence of pus during EUS-GBD(immediate after EUS-GBD.)
- Duration of the lumen apposing stent patency in the EUS-GBD arm study(the interval (days) between the time of stent placement and that of stent malfunction or patient death, whichever came first, assessed up to 12 months.)
- Technical success rate: EUS-GBD(from the beginning of the EUS-GBD procedure and 10 minutes after LAMS placement.)
- adverse events(from the beginning of the procedure until 30 days.)
- Total length of hospital stay(from the beginning of hospitalization until discharge date or death since enrollment through 12 months follow-up)
- Total health-care related cost of both arm participants.(from the end of conventional biliary drainage until the date of 12 months follow-up.)
- Need for gallbladder re-intervention.(from the end of the procedure until the date of first documented episode of acute cholecystitis through 12 months follow-up)