Comparison Between Novel Flower-type Covered Stent and Conventional Covered Stent in Malignant Extrahepatic Biliary Obstruction: Prospective Randomized Multicenter Study
试验速览
- 阶段
- 不适用
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Pancreatitis, Cholecystitis - Occurrence rate : %
研究概览
简要总结
The aim of this animal study is determining the technical feasibility of the novel flower-type covered self-expandable metal stent (F-CSEMS) and investigating whether the novel flower-type covered self-expandable metal stent (F-CSEMS) could prevent cholecystitis and pancreatitis, comparing with conventional covered self-expandable metal stent (C-CSEMS).
详细描述
Covered self-expandable metal stent (C-CSEMS) has the risk of obstruction of the cystic duct, and the main and branch pancreatic ducts due to strong radial force and covering material, which results in cholecystitis and pancreatitis.
A flower-type covered self-expandable metal stent (F-CSEMS) having a five-petal-shaped design with side grooves was constructed to prevent the obstruction of the cystic duct orifice.
This study investigated the value of the F-CSEMS in protection for cholecystitis and pancreatitis.
The investigators will enroll patients with distal MBO (Malignant Biliary Obstruction) who received placement at the Samsung Medical Center. Transpapillary flower-type covered self-expandable metal stent (F-CSEMS) placements will be included in this study.
The diagnosis of MBO will be based on imaging and/or pathological findings. Malignancy was proved by histopathological confirmation obtained by endoscopic ultrasonography-guided fine-needle aspiration (EUS-FNA), bile duct biopsy (cytology), pancreatic duct cytology, or liver biopsy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults from 19 to 85 years of age who have voluntarily agreed to the clinical trial and signed a written agreement
- •Patients with malignant extrahepatic bile duct obstruction without surgery
排除标准
- •Patients who had already undergone surgical biliary drainage
- •Patients who previously underwent percutaneous spinal cholecystectomy (PTGBD)
- •Patients who underwent conventional metal-on-metal self-expandable metal stents (C-CSEMS)
- •Patients who underwent biliary plastic stent implantation for more than 15 days
- •Patients with malignant stricture of the intrahepatic bile duct and patients with stenosis within 2 cm of the liver
- •Patients whose expected life expectancy is less than 3 months
- •Pregnant patient
- •Patients who can not undergo endoscopic procedures based on the judgment of the researcher
研究组 & 干预措施
Flower-CSEMS
EGIS Flower Biliary Full Covered Stent(Flower-CSEMS), Bile Duct Stent, (S & G Biotech Co., Ltd.) will be inserted by using Endoscopic Retrograde CholangioPancreatography(ERCP).
干预措施: Endoscopic Retrograde CholangioPancreatography(ERCP) (Device)
Conventional-CSEMS
Conventional-CSEMS (S & G Biotech Co., Ltd.) will be inserted by using Endoscopic Retrograde CholangioPancreatography(ERCP).
干预措施: Endoscopic Retrograde CholangioPancreatography(ERCP) (Device)
结局指标
主要结局
Pancreatitis, Cholecystitis - Occurrence rate : %
时间窗: 3 months after procedure
The incidence of pancreatitis is calculated using percentiles.
Pancreatitis, Cholecystitis - Severity
时间窗: 3 months after procedure
The extent of each side effect is described in the Adverse Reactions Report according to the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) Rating System version 4.0.
次要结局
- Stent-related adverse events(6 months after procedure)
- Stent patency(6 months after procedure)