跳至主要内容
临床试验/NCT05475782
NCT05475782已完成不适用

Spyglass-guided Lithotripsy Vs ESWL for Pancreatic Duct Stones

First People's Hospital of Hangzhou1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
Clinical success

研究概览

简要总结

Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for pancreatic duct stones is a amjor problem, especially bigger size stones. After ERCP failure, surgery was the only option but patients not suitable for surgery were treated through stenting. But had to undergo multiple ERCPs and show lower success rate. Recently, SpyGlass and extracorporeal shock wave lithotripsy (ESWL) have been applied for the treatment of huge stones. The present study aims to compare the efficacy and safety outcomes of SpyGlass-guided lithotripsy and ESWL procedures for the removal of pancreatic duct stones.

详细描述

ESWL was first used for the removal of renal calculi and ureteral calculi however, now a day is being used for pancreatic duct stones and biliary calculi. It has the advantages of simple operation, lower cost, and higher safety. Recent studies show that the procedure time for ESWL is also shorter and the utilization rate of mechanical lithotripsy was effectively reduced with fewer complications. But It is difficult for ESWL to break the stones larger than 3cm into small pieces.

Spyglass has been used in clinics for more than ten years. Recently, a study reported difficult bile duct stones that were treated with SpyGlass-guided laser lithotripsy that shows promising results. Compared with laser lithotripsy under X-ray monitoring, there is no significant difference in stone removal rate and complication rate between the two methods. However, the effect of lithotripsy under Spyglass direct vision is better, which can break large stones into smaller pieces, thus making it easier to take stones. Investigator conducted the current study to compare the therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL procedures for the removal of large pancreatic duct stones.

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, Care Provider)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pancreatic duct sone
  • Falied to eliminate through ERCP only

排除标准

  • Pregnancy
  • Refusal of written informed consent
  • Patients not suitable for ESWL/ Spyglass
  • Contraindications to ERCP exist
  • Complicated with acute pancreatitis or acute cholangitis
  • Coagulation dysfunction#thrombocytopenia
  • Patients after gastrointestinal reconstruction
  • Allergic to drugs

研究组 & 干预措施

Spyglass group

Active Comparator

lithotripsy through Spyglass and ERCP

干预措施: Spyglass-guided lithotripsy (Procedure)

ESWL group

Experimental

Lithotripsy through ESWL and ERCP

干预措施: ESWL (Procedure)

结局指标

主要结局

Clinical success

时间窗: 1 month

Pancreatic duct stone clearance rate

Technical success

时间窗: Intraoperative

Successfull intervention

次要结局

  • Procedure sessions(1 month)
  • Adverse events(1 month)
  • Total number of ERCP(1 month)

研究者

发起方
First People's Hospital of Hangzhou
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianfeng Yang

Professor

First People's Hospital of Hangzhou

研究点 (1)

Loading locations...

相似试验