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临床试验/CTRI/2024/05/067498
CTRI/2024/05/067498尚未招募2/3 期

A Comparative study of Continuous Catheter Drainage Versus Percutaneous Needle Aspiration for treatment of Liver Abscess : A Superiority Open label Randomised Controlled Trial

Dr Shashank Bhatkar1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月27日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Comparison of treatment outcomes in terms of clinical, biochemical and radiological parameters for treatment of patients with liver abscess, by continuous catheter drainage via pigtail and percutaneous needle aspiration respectively.

研究概览

简要总结

Liver abscess is defined as a collection of suppurative material in liver parenchyma and is one of the cystic lesions of the liver. Abscesses occur when normal hepatic metabolism is overwhelmed or the system fails. Liver abscess is a relatively common clinical problem in India and tropical countries. Liver abscesses , both amoebic and pyogenic , continue to be an important cause of morbidity and mortality in tropical countries. Liver abscess mainly affects the right lobe (~65%) much more commonly than the left lobe (~10–15%) and can also be bilobar (~20–25%). When multiple abscesses are present, pyogenic or mixed infection needs to be suspected. There are three modalities of treatment for liver abscesses -

  • Antimicrobial therapy : If pyogenic liver abscess is suspected , broad spectrum antibiotics should be started immediately till the culture results come , to control ongoing bacteremia and associated complications.

  • Interventional therapy for liver abscesses : Traditional treatment modalities have included both continuous catheter drainage and percutaneous needle aspiration, each with its own set of advantages and drawbacks.

  • Surgical Intervention : Surgical drainage has been reserved for patients who fail to respond to treatment with either aspiration or percutaneous drainage and antibiotics or who have concurrent intra-abdominal pathology which requires surgical management.

This study aims to provide a comprehensive comparison of these two surgical interventions, shedding light on their respective impacts on clinical, biochemical, and radiological parameters in patients with liver abscesses.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 72.00 Year(s)(—)
性别
All

入选标准

  • Pts aged 18-72 yrs.
  • Pts with liver abscess of cavity size 4 cm or more.
  • Pts with no prior treatment or history.
  • Pts with single or multiple abscesses.

排除标准

  • Uncorrectable coagulopathy.
  • Ruptured liver abscess.
  • Uncertain diagnosis.
  • Pregnant and less than 18 yrs of age.
  • Patients not willing for treatment.
  • Not compliant to follow-up.
  • Abscess secondary to obstructive jaundice.

结局指标

主要结局

Comparison of treatment outcomes in terms of clinical, biochemical and radiological parameters for treatment of patients with liver abscess, by continuous catheter drainage via pigtail and percutaneous needle aspiration respectively.

时间窗: Improvement in clinical parameters every 24 hours, biochemical and radiological parameters every third day and each parameter 7 days after discharge

次要结局

  • Length of hospital stay(Length of hospital stay)
  • Complications during hospital stay(Complications during hospital stay)
  • Improvement in biochemical parameters(At every 24 hours)

研究者

发起方
Dr Shashank Bhatkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shashank A Bhatkar

All India Institute of Medical Sciences, Nagpur

研究点 (1)

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