Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06007820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-23
First Post:
2023-08-05
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:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
Efficacy Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
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 5-367 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 SPRA 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 cs
4 Hemodynamics Intrapleural pressures at first TT
5 Baseline at randomization Day -3 and Day - 7 in PCD-TT -
6 Blood KFT INR SPRA Pro-BNP Urinary Na at Day 7
7 Imaging X-ray chest
8 Pleural fluid ascitic fluid - TLC DLC SPAG cs 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 Students 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 5-367 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 SPRA 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 cs
4 Hemodynamics Intrapleural pressures at first TT
5 Baseline at randomization Day -3 and Day - 7 in PCD-TT -
6 Blood KFT INR SPRA Pro-BNP Urinary Na at Day 7
7 Imaging X-ray chest
8 Pleural fluid ascitic fluid - TLC DLC SPAG cs 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 Students 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:
None
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?:
None