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

Hepatic Hydrothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06007820
• Other study ID #: ILBS-Cirrhosis-60
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: February 27, 2024

Study information

• Verified date: August 2023
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Jaifrin Daniel, MD
• Phone: 01146300000
• Email: jdaniel.m07[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

• 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

1. Etiology of chronic liver disease (Baseline) 2. Severity of liver disease (Baseline, Day - 7, Day - 30, Day - 90 ) 3. MELD score, MELD-Na score, CTP score (Baseline, Day - 7, Day - 30, Day - 90 ) 4. Complications (Baseline, Day - 7, Day - 30, Day - 90 ) 5. Overt HE, PHT related Bleed, clinical jaundice, ascites, hyponatremia, AKI, SBP, Infection (specify site and severity), Frequency of Large Volume Paracentesis, On Demand Thoracocentesis

• Labs and follow up Baseline (at admission) -

1. Blood : KFT, LFT, CBC, INR, AFP, PCT, S.PRA, Pro-BNP, Urinary Na

2. Imaging : USG abdomen, X-ray chest, 2D ECHO

3. Pleural fluid/ ascitic fluid - TLC, DLC, Protein, Sugar, SPAG, SAAG, ADA, c/s

4. Hemodynamics : Intrapleural pressures at first TT

5. Baseline (at randomization, Day -3 and Day - 7 in PCD-TT) -

6. Blood : KFT, INR; S.PRA, Pro-BNP, Urinary Na (at Day 7)

7. Imaging : X-ray chest

8. Pleural fluid/ ascitic fluid - TLC, DLC, SPAG, c/s if indicated

9. Day - 60, Day - 90 (end of follow-up)

10. Blood : KFT, LFT, CBC, INR, AFP

11. Imaging : USG abdomen, X-ray chest, 2D ECHO

• STATISTICAL ANALYSIS -

1. Data will be reported as mean + SD.

2. Categorical variables will be compared using the chi-square test or Fisher exact test

3. Normal continuous variables will be compared using the Student's t test

4. Non normal continuous variables will be compared using the Mann-Whitney rank-sum test (unpaired data) or the Wilcoxon test (paired data).

5. The actuarial probability of survival will be calculated by the Kaplan-Meier method and compared using the log-rank test.

6. A Cox regression analysis will be performed to identify independent prognostic factors for survival.

7. Univariate and multivariate analysis will be used whenever applicable.

• Adverse effects - Chest pain, pain at the site, Breathlessness, infection, pneumothorax, infection, bleeding

• Stopping rule -

1. Liver Transplant

2. Appearance of SBP, PICD, HE.

3. Mortality

4. End of follow-up

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years

2. CLD with refilling symptomatic hepatic hydrothorax

Exclusion Criteria:

1. CTP >12, MELD>25

2. Tubercular PE, Ischemic cardiac disease

3. If opting for TIPS/ LT

4. Severe HPS

5. Prior or current SBE/ SBP, septic shock

6. Patients on mechanical ventilator

7. Serum Creatinine >2 mg/dl

8. Extrahepatic malignancy

9. Serum Sodium < 120

10. Post TIPS/ BRTO/ SAE patients

11. Post renal or liver transplantation

12. Lack of informed consent

13. Hepatocellular carcinoma outside milan criteria

14. Non-cirrhotic portal HT

15. Known HIV infection

16. Pregnant women

Related Conditions & MeSH terms

• Hepatic Hydrothorax
• Hydrothorax

Intervention

Procedure:
• Large Volume Thoracocentesis
Large Volume Thoracocentesis
• Pigtail Catheter
Pigtail Catheter

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Repeated Thoracocentesis		Day 30
Primary	Frequency of Repeated Thoracocentesis		Day 90
Secondary	Incidence of refilling hydrothorax within		72 hours
Secondary	Frequency of Repeated Thoracocentesis.		Day 30 and Day 90
Secondary	Rate of Complete Response, Partial Response, No response.		Day 7, Day 30, Day 90
Secondary	Number of times Thoracocentesis is required between both groups at Day 30		Day 30
Secondary	Number of times Thoracocentesis is required between both groups at Day 90		Day 90
Secondary	Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 7		Day 7
Secondary	Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 30		Day 30
Secondary	Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 90		Day 90
Secondary	Change in Renal parameters - Serum Creatinine at Day 7		Day 7
Secondary	Change in Renal parameters - Serum Creatinine at Day 30		Day 30
Secondary	Change in Renal parameters - Serum Creatinine at Day 90		Day 90
Secondary	Hepatic encephalopathy: Grading as per West Haven Classification.	West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.	Day 7
Secondary	Hepatic encephalopathy: Grading as per West Haven Classification.	West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.	Day 30
Secondary	Hepatic encephalopathy: Grading as per West Haven Classification.	West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.	Day 90
Secondary	Proportion of participants developing Na < 120 meg/l Day 7		Day 7
Secondary	Proportion of participants developing Na < 120 meg/l Day 30		Day 30
Secondary	Proportion of participants developing Na < 120 meg/l Day 90		Day 90
Secondary	Dose of Diuretic in each arm Day 7		Day 7
Secondary	Dose of Diuretic in each arm Day 30		Day 30
Secondary	Dose of Diuretic in each arm Day 90		Day 90
Secondary	Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 7		Day 7
Secondary	Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 30		Day 30
Secondary	Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 90		Day 90
Secondary	Proportion of patients developing Spontaneous Bacterial Empyema Day 7		Day 7
Secondary	Proportion of patients developing Spontaneous Bacterial Empyema Day 30		Day 30
Secondary	Proportion of patients developing Spontaneous Bacterial Empyema Day 90		Day 90
Secondary	No. of days pateint surviving without Liver transplant and TIPS at Day 7		Day 7
Secondary	No. of days pateint surviving without Liver transplant and TIPS at Day 30		Day 30
Secondary	No. of days pateint surviving without Liver transplant and TIPS at Day 90		Day 90
Secondary	Incidence of Post procedure complications in between both groups at Day 7		Day 7
Secondary	Incidence of Post procedure complications in between both groups at Day 30		Day 30
Secondary	Incidence of Post procedure complications in between both groups at Day 90		Day 90
Secondary	Changes in MELD between the groups		Day 7
Secondary	Changes in MELD between the groups		Day 30
Secondary	Changes in MELD between the groups		Day 90
Secondary	Changes in CTP between the groups		Day 7
Secondary	Changes in CTP between the groups		Day 30
Secondary	Changes in CTP between the groups		Day 90
Secondary	Number of Episodes of Hospitalization between both groups at Day 7		Day 7
Secondary	Number of Episodes of Hospitalization between both groups at Day 30		Day 30
Secondary	Number of Episodes of Hospitalization between both groups at Day 90		Day 90
Secondary	Cumulative dose of albumin at D7 in two groups		Day 7
Secondary	Cumulative dose of albumin at D30 in two groups		Day 30
Secondary	Cumulative dose of albumin at D90 in two groups		Day 90