Comparison of Early Needle-knife Precut Papillotomy Over a Pancreatic Stent and Transpancreatic Sphincterotomy in Difficult Cannulation: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Success rate of common bile duct (CBD) cannulation
研究概览
简要总结
Hello. This study is about a special kind of endoscopy called ERCP, which is used to treat bile duct infections, gallstones, and blockages that cause jaundice. Normally, doctors use a standard method to insert a tube into the bile duct during the procedure. However, even skilled doctors sometimes have trouble - in about 10% to 20% of patients, it's difficult to get the tube in.
When this happens, doctors use advanced techniques called "precut" methods to help make the procedure successful. One of these is called "early needle-knife precut," which is done after trying for 5 minutes without success. Studies have shown this method can reduce the chance of getting pancreatitis (inflammation of the pancreas) afterward.
There are two common types of these advanced techniques:
Needle-knife precut over a pancreatic stent, which gently opens the area using a small cut over a temporary plastic tube.
Transpancreatic sphincterotomy, which also helps open the duct through a different approach.
Both methods can help the procedure succeed and have similar safety results. However, not many studies have compared these two methods early on in the procedure when a pancreatic stent is used.
This study wants to compare them in a safe and scientific way. If you or your family member agrees to join, the doctor will explain everything clearly. Joining is completely voluntary, and saying "no" will not affect the medical care you receive.
详细描述
Purpose of the Study
This research compares two different advanced techniques used during a special endoscopy procedure (called ERCP) when it is difficult to insert a tube into the bile duct. The goal is to see which method is more successful, takes less time, and causes fewer complications:
Needle-knife precut over a pancreatic stent, and
Transpancreatic sphincterotomy (cutting through the pancreatic opening).
Who Can Join the Study?
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
- Single (Participant)
盲法说明
Patients are randomized into two groups at the time of providing informed consent by a 1:1 ratio, by opening a sealed envelope containing a noted marked with both groups.
入排标准
- 年龄范围
- 20 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 20 years old and needed ERCP intervention for obstructive jaundice. They presented the "difficult CBD cannulation".
排除标准
- •Patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD)
- •Previous sphincterotomy,
- •Peripapillary diverticula,
- •Active pancreatitis,
- •Prior gastric surgery,
- •Current use of antiplatelet agents,
- •Coagulopathy,
- •Peri-ampullary tumor-related obstruction,
- •Pregnancy,
- •Refused or were unable to give informed consent
结局指标
主要结局
Success rate of common bile duct (CBD) cannulation
时间窗: During the ERCP procedure (up to 60 minutes)
Successful selective biliary cannulation using the assigned intervention during the index ERCP session.
次要结局
- Incidence of post-ERCP pancreatitis (PEP)(Within 24 hours after ERCP)
- Incidence of perforation(Within 72 hours after ERCP)
研究者
Liang Chih-Ming
Deputy Director of Division of Hepato-Gastroenterology, Clinical Associate Professor.
Chang Gung Memorial Hospital
