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临床试验/NCT04625712
NCT04625712已完成不适用

Multicenter Prospective Randomized Study to Choose the Optimal Moment of Colecistectomy After Mild Biliary Pancreatitis

Consorci Sanitari Integral0 个研究点目标入组 220 人开始时间: 2017年1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
220
主要终点
Number of patients presenting morbidity associated with cholescystectomy

研究概览

简要总结

Introduction Acute pancreatitis is the third gastrointestinal cause of hospital admission. It is estimated that 35-60% have a biliary origin, and most of them are mild.

After a mild acute biliary pancreatitis (ABP), there is a high risk of recurrence of others biliary events. 15-20% of patients will suffer another pancreatitis, cholangitis, choledocolithiasis, or cholecystitis. Therefore, is necessary a definitive treatment.

Although it is suggested to perform cholecystectomy early, there is still insufficient scientific evidence on this subject. All publications have biases and do not allow establish recommendations. In addition, the usual clinical practice tends to postpone the cholecystectomy, because of doubts about the safety of early intervention and for hospital logistical reasons. On the other hand, is discussing if early cholecystectomy carried out more persistence of residual cholelithiasis, explains for the pathophysiology of the ABP.

Finally, it is important to mention, that in our environment 25% of the patients with an ABP are more than 75 years old. There are not any trial that includes this age group.

Objectives Demonstrate that early cholecystectomy is feasible in all patients, including elderly patients, and decreases the number of readmissions for other biliary events.

Material and Methods It is being done a multicenter prospective randomized trial. After an ABP, patients are randomized in two treatment branches. Group A is cholecystectomy within the first week after the ABP. Group B four weeks later.

There are collect data from demographic information, comorbidities, biliary events before the surgery, residual choledocolithiasis, difficulty of the surgical technique, postoperative complications and patients are follow-up for 6 months.

To obtain a representative sample of the population, we consider it appropriate to include all age groups, including patients older than 75 years.

Expected results With this study we pretend to demonstrate that early cholecystectomy is feasible and safe. It does not increase the number of residual choledocolithiasis, and prevents readmissions for new biliary events.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Age ≥ 18 years.
  • Diagnosis of acute mild biliary pancreatitis according to Altanta 2012 criteria.
  • Signed informed consent. Exclusion Criteria
  • Alcohol abuse or chronic pancreatitis.
  • Not having assessed the presence of residual choledocolithiasis (cholangioNMR / intraoperative cholangiography)
  • Pregnancy.

排除标准

  • 未提供

结局指标

主要结局

Number of patients presenting morbidity associated with cholescystectomy

时间窗: 30 days after surgical intervention

Number of patients with surgical complications

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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