Efficacy and Safety of Single Plastic Stent Compared With Fully Covered Self-Expanding Metal Stent on Benign Biliary Stricture Secondary to Chronic Pancreatitis: A Single Center，Prospective，Non-inferiority, Open Label, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Long-term stricture resolution
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy and safety of a single plastic stent versus a fully covered self-expanded metal stent in relieving benign biliary stricture secondary to chronic pancreatitis. The main questions it aims to answer is:
Whether the efficacy of a single plastic stent is non-inferior to that of a fully covered metal stent in patients with benign biliary stricture secondary to chronic pancreatitis？
Participants will be randomly assigned to receive either a single plastic stent (SPS) placement or fully covered self-expanded metal stent placement treatment for 6 months, and they will be followed up for 18 months.
详细描述
Although a number of previous studies have shown that the drainage and dilation effect of a single plastic stent is limited for benign biliary stricture (BBS) secondary to chronic pancreatitis (CP), the poor management of CP itself in most studies may explain the unsatisfactory efficacy of a single biliary plastic stent in relieving CP secondary BBS. Investigators believe that the effective management of CP is an important step to solve the BBS secondary to CP, especially the effective removal of pancreatic duct stones, the relief of pancreatic duct obstruction and the maintenance of pancreatic duct patency. Previous data showed that in CP patients treated with ESWL combined with ERCP, 72.4% could achieve complete removal of main pancreatic duct stones and 90.8% could achieve successful endoscopic decompression. Under the premise of effectively removing the stones of the main pancreatic duct at the head of the pancreas and maintaining the patency of the pancreatic duct, using a single plastic stent for stent drainage of BBS is effective, and a single plastic stent has potential advantages such as lower stent displacement rate and cheaper. Therefore, investigators design a single-center, prospective, open-label, randomized controlled, non-inferiority trial to compare the effectiveness, safety, and cost-effectiveness of a single plastic stent and fcSEMS for the removal of CP secondary BBS under the premise that the primary disease, i.e. CP itself, was effectively managed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older;
- •Patients diagnosed with CP;
- •Symptomatic biliary stricture documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had 1 prior plastic stent inserted: cholangitis, and/or an increase in total bilirubin or alkaline phosphatase levels(> 2 times the upper limit of normal) for more than 4 weeks;
- •Confirmation of bile duct stricture by imaging assessment.
排除标准
- •Prior plastic stenting exceeding six months or any metal stenting;
- •Incomplete removal of stones from the main pancreatic duct located in the head of the pancreas during ERCP procedures;
- •Biliary stricture of benign etiology other than chronic pancreatitis;
- •Developing obstructive biliary symptoms associated with an attack of acute pancreatitis;
- •Stricture within 2 cm of common bile duct bifurcation;
- •Biliary stricture of malignant etiology;
- •Patients with acute or chronic hepatitis, cirrhosis, primary sclerosing cholangitis, congenital biliary malformations or biliary fistula;
- •Symptomatic duodenal stenosis (with gastric stasis);
- •Subjects for whom endoscopic techniques are contraindicated;
- •Pregnancy, incarceration;
- •Life expectancy < 1 year;
- •Other conditions that inappropriate to participant in the study.
结局指标
主要结局
Long-term stricture resolution
时间窗: 2 years after enrollment
Stricture resolution assessed at the time of final stent removal as well as the absence of objective findings of stricture recurrence during the 18 months, post-stenting follow-up period.
次要结局
- Number of ERCP procedures after Initial stent placement.(6 months after enrollment)
- Number of stents placed(6 months after enrollment)
- Early clinical success(6 months after enrollment)
- Technical success(6 months after enrollment)
- Adverse events related to the device or procedure(2 years after enrollment)
- Length of stent placement and removal procedures(6 months after enrollment)