Covered Self-expandable Metal Stents Versus Multiple Plastic Stents for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Stricture resolution of the common bile duct in the two study groups
研究概览
简要总结
Benign biliary strictures can be endoscopically treated with plastic or self-expandable metal stents (SEMS). The purpose of the prospective randomized study is to compare the safety and feasibility of covered SEMS with multiple plastic stents in the treatment of benign biliary stricture caused by chronic pancreatitis.
详细描述
All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study.
At the initial ERCP, an endoscopic sphincterotomy will be performed and one 10 Fr plastic stent will be inserted for the initial treatment of cholestasis in all patients.Pancreatic stent will be inserted if indicated. One to three months after the initial ERCP the patients will be randomized into two groups: those who receive cSEMS and those who receive multiple plastic stents into the bile duct. For the randomization, sealed envelopes will be used. As for cSEMSs, removable cSEMSs with diameter of 10 mm will be placed. A dilation with a 8-10mm balloon will be performed before and after the stent placement to secure the stent expansion. As for plastic stents, minimum three simultaneous 10 Fr stents will be inserted after 8-10 mm balloon dilation.
After three months a further ERCP will be performed. The number of plastic stents will be increased maximally to six 10 Fr stents after dilation if possible. In the group with cSEMS, the position of the stent will be controlled.
Once the cSEMS or plastic stents have been in place for minimum six months, the stents will be removed at the last ERCP.
Follow-up
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Benign biliary stricture caused by chronic pancreatitis
排除标准
- •Malignancy, cirrhosis acute/chronic hepatitis or abnormal hepatic imaging. First attack of acute pancreatitis.
结局指标
主要结局
Stricture resolution of the common bile duct in the two study groups
时间窗: 2.5 years
Stricture resolution during stenting and follow-up period, defined by normal liver function tests and abdominal ultrasonography
次要结局
- Stent removability(Time from stent removal to 1 month post-stent removal)
- Occurrence of complications related to stents and procedure(2.5 years)
- Length of endoscopic procedures in the two groups(All endoscopic procedures)
研究者
Halttunen Jorma
Jorma Halttunen, MD, PhD
Helsinki University Central Hospital