跳至主要内容
临床试验/NCT04077008
NCT04077008Unknown不适用

Mode of Drainage Of Bilaterally Obstructed Kidneys Due to Benign or Malignant Causes: A Prospective Comparative Study

Assiut University0 个研究点目标入组 100 人开始时间: 2019年8月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
when the serum creatinine comes to normal after drainage of bilaterally obstructed kidneys either on one side or 2 sides

研究概览

简要总结

Bilaterally obstructed kidneys could be caused by benign or malignant causes it could lead to renal failure which can be avoided by urgent drainage either by PCN or DJ , The aim is to determine whether unilateral or bilateral drainage make a difference in improvement of renal function of bilaterally obstructed kidneys and whether that improvement relays on the cause of the obstruction.

The investigators will do that by doing a prospective comparative study on patients presented to our department by bilaterally obstructed kidneys , by either benign or malignant causes , with high serum chemistry. Intervention to this cases will be done by inserting JJ or PCN either unilateral or bilateral depending upon lab workups , our staff decision and patients fittness and agreement .

详细描述

Kidney obstruction means obstruction of urinary flow with back pressure on the kidney, which may be unilateral or bilateral, may have many causes either benign e.g; urolithiasis, retroperitoneal fibrosis, renal papillary necrosis or malignant e.g; urinary tract tumors as bladder cancer and prostate cancer, or Extrinsic tumor as cervical cancer(5) , lymphoma or other pelvic tumors When kidney obstruction occurs bilaterally this raises serum chemistry and may lead to post-renal AKI which represents about (1-10%) of all causes of AKI. Post-renal AKI is an emergency case that requires an urgent and minimally invasive procedure to drain the urine either by PCN or ureteric stents.

There has been always a debate about which one is better to drain the obstructed kidneys percutaneous nephrostomy or ureteric stents and which is better in improvement of renal function and with less effect on life style . Also the mode of drainage of the obstructed kidneys, bilateral or unilateral, also has been a point of debate. Unless bilateral renal obstruction is due to benign or treatable malignant cause, unilateral nephrostomy is always the rule according to some authors . some authors, reported better improvement in renal function with bilateral PCN with pelvic tumors The investigators will do prospective comparative study for studying mode and laterality of drainage in benign and malignant causes in bilaterally obstructed kidneys .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Screening
盲法
None

入排标准

年龄范围
12 Months 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adult patients ( >18 yrs ) with bilateral obstructed kidneys
  • Bilateral obstructed kidneys due to benign causes
  • Bilateral obstructed kidneys due to malignant causes
  • Bilateral obstructed kidneys with high serum creatinine

排除标准

  • Age < 18 yrs
  • Bilateral obstructed kidneys with normal serum creatinine
  • patients with chronic kidney disease
  • Vesicoureteric reflux
  • Severe comorbidity preventing intervention

研究组 & 干预措施

Bilaterally Obstructed Kidneys by benign cause

Other

干预措施: bilateral drainage of Bilaterally Obstructed Kidneys (Procedure)

Bilaterally Obstructed Kidneys by benign cause

Other

干预措施: unilateral drainage of Bilaterally Obstructed Kidneys (Procedure)

Bilaterally Obstructed Kidneys by malignant cause

Other

干预措施: unilateral drainage of Bilaterally Obstructed Kidneys (Procedure)

Bilaterally Obstructed Kidneys by malignant cause

Other

干预措施: bilateral drainage of Bilaterally Obstructed Kidneys (Procedure)

结局指标

主要结局

when the serum creatinine comes to normal after drainage of bilaterally obstructed kidneys either on one side or 2 sides

时间窗: 2 years

The investigators will measure seum creatinine of patients with bilaterally obstructed kidneys and raised serum chemistry who are in urgent need for intervention . After intervention , either by PCn or ureteric stents , serum chemistry will be measured in those patient again in fixed times e.g; after 6 hrs , 1 day , 3 days , 1 week , 2 weeks . after collecting and processing the data we will come to a conclusion either bilateral drainage of patients with bilaterally obstructed kidneys due to benign cause is faster to return serum chemistry to normal than unilateral drainage. The same will be applied to patients of bilaterally obstructed kidneys due to malignant cause .

次要结局

未报告次要终点

研究者

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

Ahmed Mahmoud Abdelraouf

Resident at Urology Hospital at Assiut University

Assiut University

相似试验