Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT06007820
Status:
UNKNOWN
Last Update Posted:
2023-08-23
First Post:
2023-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy & Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax.
Sponsor:
Institute of Liver and Biliary Sciences, India
Organization:
Study Overview
Official Title:
Efficacy & Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax. A Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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
* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: