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临床试验/NCT06007820
NCT06007820尚未招募不适用

Efficacy & Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax. A Randomized Controlled Trial

Institute of Liver and Biliary Sciences, India2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年8月15日最近更新:
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适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
2
主要终点
Frequency of Repeated Thoracocentesis
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In cirrhotic patients with recurrent hepatic hydrothorax liver transplantation is a definitive treatment. But a significant number of individual are ineligible for liver transplantation. In these patients to ameliorate the symptoms various treatment modalities such as TIPS, serial thoracocentesis, pigtail catheter drainage and pleurodesis are used. We are doing this study to assess the safety and efficacy of serial thoracocentesis verus pigtail catheter drainage.

详细描述

  • Study population - Cirrhotic patients with recurrent hepatic hydrothorax
  • Study design - A prospective, randomized, single center open label study
  • Block Randomization, block size - 10
  • Sample size - Assuming in single time thoracocentesis group 5+/-3.67 thoracocentesis is required, investigator expect a 50 % reduction in pigtail drainage group. Apha error- 5, power -90, 15% dropout 35 patients in each arm
  • Intervention - Group 1 - on-demand therapeutic thoracocentensis, Group 2 - small volume frequent thoracocentesis using PCD.
  • Monitoring and assessment
  • At enrollment:

(A) Complete history and examination

  1. Etiology of cirrhosis
  2. Severity of ascites, Jaundice
  3. Prior Hepatic encephalopathy, bleed, Jaundice
  4. Prior Spontaneous bacterial peritonitis, large volume paracentesis frequency
  5. Pattern and number of prior decompensation
  6. Prior Acute on Chronic Liver Failure and Acute Kidney episodes
  7. Use of non selective beta blockers, norfloxaxin, rifaximin and albumin
  8. History of Endoscopic Variceal ligation or other endotherapy
  9. History of Hypertension, Diabetes
  10. Fever , signs of sepsis (SIRS)
  11. Examination- Sarcopenia, fraility, icterus, pedal edema

At follow-up (at daily till Day - 7, thereafter at Day - 30 and Day 90) Complete history and examination

  1. Complications - SBP, SBE, ACLF and Jaundice, HE/ AKI episodes
  2. HTN, Diabetes control
  3. Fever , signs of sepsis (SIRS)
  4. Examination- Sarcopenia, fraility, icterus, pedal edema, ascites, HE Clinical Evaluation

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
None

入排标准

年龄范围
18 Years 至 75 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-75 years
  • •CLD with refilling symptomatic hepatic hydrothorax

排除标准

  • •CTP >12, MELD>25
  • •Tubercular PE, Ischemic cardiac disease
  • •If opting for TIPS/ LT
  • •Prior or current SBE/ SBP, septic shock
  • •Patients on mechanical ventilator
  • •Serum Creatinine >2 mg/dl
  • •Extrahepatic malignancy
  • •Serum Sodium < 120
  • •Post TIPS/ BRTO/ SAE patients
  • •Post renal or liver transplantation
  • •Lack of informed consent
  • •Hepatocellular carcinoma outside milan criteria
  • •Non-cirrhotic portal HT
  • •Known HIV infection
  • •Pregnant women

结局指标

主要结局

Frequency of Repeated Thoracocentesis

时间窗: Day 90

次要结局

  • Cumulative dose of albumin at D90 in two groups(Day 90)
  • No. of days pateint surviving without Liver transplant and TIPS at Day 7(Day 7)
  • Hepatic encephalopathy: Grading as per West Haven Classification.(Day 90)
  • Number of times Thoracocentesis is required between both groups at Day 30(Day 30)
  • Change in Renal parameters - Serum Creatinine at Day 7(Day 7)
  • Change in Renal parameters - Serum Creatinine at Day 30(Day 30)
  • Frequency of Repeated Thoracocentesis.(Day 30 and Day 90)
  • Change in Renal parameters - Serum Creatinine at Day 90(Day 90)
  • Dose of Diuretic in each arm Day 30(Day 30)
  • Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 90(Day 90)
  • Incidence of refilling hydrothorax within(72 hours)
  • Number of times Thoracocentesis is required between both groups at Day 90(Day 90)
  • Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 7(Day 7)
  • Rate of Complete Response, Partial Response, No response.(Day 7, Day 30, Day 90)
  • Proportion of participants developing Na < 120 meg/l Day 30(Day 30)
  • Proportion of patients developing Spontaneous Bacterial Empyema Day 7(Day 7)
  • Proportion of participants developing Na < 120 meg/l Day 7(Day 7)
  • Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 30(Day 30)
  • Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 90(Day 90)
  • Proportion of patients developing Spontaneous Bacterial Empyema Day 30(Day 30)
  • No. of days pateint surviving without Liver transplant and TIPS at Day 90(Day 90)
  • No. of days pateint surviving without Liver transplant and TIPS at Day 30(Day 30)
  • Proportion of participants developing Na < 120 meg/l Day 90(Day 90)
  • Dose of Diuretic in each arm Day 7(Day 7)
  • Dose of Diuretic in each arm Day 90(Day 90)
  • Incidence of Post procedure complications in between both groups at Day 90(Day 90)
  • Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 7(Day 7)
  • Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 30(Day 30)
  • Proportion of patients developing Spontaneous Bacterial Empyema Day 90(Day 90)
  • Incidence of Post procedure complications in between both groups at Day 30(Day 30)
  • Changes in CTP between the groups(Day 90)
  • Number of Episodes of Hospitalization between both groups at Day 7(Day 7)
  • Number of Episodes of Hospitalization between both groups at Day 90(Day 90)
  • Number of Episodes of Hospitalization between both groups at Day 30(Day 30)
  • Incidence of Post procedure complications in between both groups at Day 7(Day 7)
  • Cumulative dose of albumin at D7 in two groups(Day 7)
  • Cumulative dose of albumin at D30 in two groups(Day 30)
  • Changes in MELD between the groups(Day 90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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