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临床试验/NCT04494282
NCT04494282已完成不适用

The Economic Impact of the Pancreatography in the Endoscopic Treatment of Pancreatic Pseudocysts

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran0 个研究点目标入组 50 人开始时间: 2015年8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
50
主要终点
The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts

研究概览

简要总结

Pancreatic pseudocysts (PP) present as a complication that occurs in 5-15% of acute pancreatitis and 26-40% of chronic pancreatitis (1-3). To date the endoscopic drainage with endoscopic ultrasound (EUS) has replace the surgical treatment due to the similar success and complication rate but with a lower cost and short hospital stay (4-6). Regarding recurrence, it is important to know the anatomy of the main pancreatic duct (MPD). For this purpose, the endoscopic retrograde pancreatography (ERP) has been describe as a useful tool. In fact, many authors perform it before the endoscopic drainage while others wait several weeks after the drainage (7-9) with similar technical success (5,8). However, there are no studies that compare the technical difficulty and the total cost between these two approaches.

详细描述

METHODS: Random control trial between two groups. Group 1 the ERP will be performed the same day of the endoscopic drainage of PP. Group 2 the ERP will be performed 6 weeks after the endoscopic drainage of PP. Each ERP will be performed by an expert in ERP in patients who fulfilled the Atlanta criteria for PP. The patients will be enrolled and informed consent will be explained and signed. In those patients who ERP fails, a second attempt will be performed 6 weeks after the endoscopic drainage of PP (Group 1) or a magnetic resonance cholangiopancreatography will be performed (Group 2).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Pancreatic pseudocyst that fulfilled the Atlanta Classification
  • •Symptomatic pancreatic pseudocyst
  • •Informed consent obtained

排除标准

  • •Patient unwilling to participate
  • •Absence of duration time of the pancreatography procedure in the record
  • •Absence of the number of weeks between the drainage and the pancreatography

研究组 & 干预措施

Same day

Active Comparator

The ERP will be performed the same day of the endoscopic drainage of PP

干预措施: Endoscopic retrograde pancreatography (Procedure)

Other day

Active Comparator

The ERP will be performed 6 weeks after the endoscopic drainage of PP.

干预措施: Endoscopic retrograde pancreatography (Procedure)

结局指标

主要结局

The impact of the pancreatography in the endoscopic treatment of pancreatic pseudocysts

时间窗: 6 weeks

Determine the impact of the timing performing an endoscopic pancreatography in relation of the drainage of pancreatic pseudocyst

次要结局

未报告次要终点

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Saúl

Principal investigator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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