跳至主要内容
临床试验/NCT04628273
NCT04628273已完成不适用

A Prospective Cohort Study of Large Pancreatic Radiolucent Stone

Changhai Hospital0 个研究点目标入组 52 人开始时间: 2011年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
主要终点
rate of pain relief

研究概览

简要总结

Treatment strategy of chronic pancreatitis (CP) patients with large pancreatic radiolucent stone (≥ 5mm) has not been established. We aimed to figure out clinical features and efficacy of endotherapy for large pancreatic radiolucent stone.

详细描述

  1. Treatment strategy of CP patients with large pancreatic stone:

  2. . For patients with large radiolucent stone,ERCP with balloon sphincteroplasty was performed directly to remove radiolucent stone. If ERCP intubation failed, endoscopic ultrasound-guided drainage of pancreatic duct, surgery or medication would be applied. ESWL was performed in the following situations. Frist, MPD strictures was so severe that dilation catheter can not be inserted during ERCP. Second, there was cystic dilatation in MPD and pancreatic radiolucent stone located in cystic dilatation could not be extracted by extraction balloon or basket. In the above cases, the naso-pancreatic catheterwas inserted during ERCP, and then ESWL would be performed with repeated injection of contrast medium. After ESWL, repeated washing and negative pressure drainage were performed, and at last contrast medium was injected again to make sure the stones were cleared. For patients without MPD strictures, the nasopancreatic catheter can be directly removed, otherwise the nasopancreatic duct would be cut off into a stent.

  3. . For patients with large radiopaque stone, repeated P-ESWL sessions were performed, and ERCP was routinely performed 48 hours after the last P-ESWL. If ERCP intubation failed, medication or surgery would be recommended.

  4. A prospective cohort study was conducted in CP patients with large radiolucent stone. Patients with large radiopaque stone were matched as the control group, with a ratio of 1:2 according to admission time.

  5. The primary outcome was pain relief. The secondary outcomes were stone clearance, quality of life score, and changes in pancreatic exocrine and endocrine function.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Clinical diagnosis of chronic pancreatitis; With pancreatic radiolucent stones large than 5mm

排除标准

  • •Autoimmune pancreatitis; Groove pancreatitis; Pancreatic cancer diagnosed within 2 years after diagnosis of chronic pancreatitis

结局指标

主要结局

rate of pain relief

时间窗: after treatment to 2020-01-30

Pain relief is evaluated by Izbicki pain score and classified as complete relief (Izbicki pain score ≤ 10) or partial relief (Izbicki pain score \> 10 after a decrease of \> 50%)

次要结局

  • score of life quality(after treatment to 2020-01-30)
  • rate of stone clearance(during ERCP procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhaoshen Li

Director of Gastroenterology,Changhai Hospital;Academician of Chinese Academy of Engineering

Changhai Hospital

相似试验