xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06007820</url>
    </required_header>
    <id_info>
      <org_study_id>ILBS-Cirrhosis-60</org_study_id>
      <nct_id>NCT06007820</nct_id>
    </id_info>
    <brief_title>Efficacy &amp; Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax.</brief_title>
    <official_title>Efficacy &amp; Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax. A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Liver and Biliary Sciences, India</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Liver and Biliary Sciences, India</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In cirrhotic patients with recurrent hepatic hydrothorax liver transplantation is a&#xD;
        definitive treatment. But a significant number of individual are ineligible for liver&#xD;
        transplantation. In these patients to ameliorate the symptoms various treatment modalities&#xD;
        such as TIPS, serial thoracocentesis, pigtail catheter drainage and pleurodesis are used. We&#xD;
        are doing this study to assess the safety and efficacy of serial thoracocentesis verus&#xD;
        pigtail catheter drainage.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  Study population - Cirrhotic patients with recurrent hepatic hydrothorax&#xD;
  &#xD;
          -  Study design - A prospective, randomized, single center open label study&#xD;
  &#xD;
          -  Block Randomization, block size - 10&#xD;
  &#xD;
          -  Sample size - Assuming in single time thoracocentesis group 5+/-3.67 thoracocentesis is&#xD;
             required, investigator expect a 50 % reduction in pigtail drainage group. Apha error- 5,&#xD;
             power -90, 15% dropout 35 patients in each arm&#xD;
  &#xD;
          -  Intervention - Group 1 - on-demand therapeutic thoracocentensis, Group 2 - small volume&#xD;
             frequent thoracocentesis using PCD.&#xD;
  &#xD;
          -  Monitoring and assessment&#xD;
  &#xD;
          -  At enrollment:&#xD;
  &#xD;
        (A) Complete history and examination&#xD;
  &#xD;
          1. Etiology of cirrhosis&#xD;
  &#xD;
          2. Severity of ascites, Jaundice&#xD;
  &#xD;
          3. Prior Hepatic encephalopathy, bleed, Jaundice&#xD;
  &#xD;
          4. Prior Spontaneous bacterial peritonitis, large volume paracentesis frequency&#xD;
  &#xD;
          5. Pattern and number of prior decompensation&#xD;
  &#xD;
          6. Prior Acute on Chronic Liver Failure and Acute Kidney episodes&#xD;
  &#xD;
          7. Use of non selective beta blockers, norfloxaxin, rifaximin and albumin&#xD;
  &#xD;
          8. History of Endoscopic Variceal ligation or other endotherapy&#xD;
  &#xD;
          9. History of Hypertension, Diabetes&#xD;
  &#xD;
         10. Fever , signs of sepsis (SIRS)&#xD;
  &#xD;
         11. Examination- Sarcopenia, fraility, icterus, pedal edema&#xD;
  &#xD;
        At follow-up (at daily till Day - 7, thereafter at Day - 30 and Day 90) Complete history and&#xD;
        examination&#xD;
  &#xD;
          1. Complications - SBP, SBE, ACLF and Jaundice, HE/ AKI episodes&#xD;
  &#xD;
          2. HTN, Diabetes control&#xD;
  &#xD;
          3. Fever , signs of sepsis (SIRS)&#xD;
  &#xD;
          4. Examination- Sarcopenia, fraility, icterus, pedal edema, ascites, HE Clinical Evaluation&#xD;
  &#xD;
        1. Etiology of chronic liver disease (Baseline) 2. Severity of liver disease (Baseline, Day -&#xD;
        7, Day - 30, Day - 90 ) 3. MELD score, MELD-Na score, CTP score (Baseline, Day - 7, Day - 30,&#xD;
        Day - 90 ) 4. Complications (Baseline, Day - 7, Day - 30, Day - 90 ) 5. Overt HE, PHT related&#xD;
        Bleed, clinical jaundice, ascites, hyponatremia, AKI, SBP, Infection (specify site and&#xD;
        severity), Frequency of Large Volume Paracentesis, On Demand Thoracocentesis&#xD;
  &#xD;
          -  Labs and follow up Baseline (at admission) -&#xD;
  &#xD;
               1. Blood : KFT, LFT, CBC, INR, AFP, PCT, S.PRA, Pro-BNP, Urinary Na&#xD;
  &#xD;
               2. Imaging : USG abdomen, X-ray chest, 2D ECHO&#xD;
  &#xD;
               3. Pleural fluid/ ascitic fluid - TLC, DLC, Protein, Sugar, SPAG, SAAG, ADA, c/s&#xD;
  &#xD;
               4. Hemodynamics : Intrapleural pressures at first TT&#xD;
  &#xD;
               5. Baseline (at randomization, Day -3 and Day - 7 in PCD-TT) -&#xD;
  &#xD;
               6. Blood : KFT, INR; S.PRA, Pro-BNP, Urinary Na (at Day 7)&#xD;
  &#xD;
               7. Imaging : X-ray chest&#xD;
  &#xD;
               8. Pleural fluid/ ascitic fluid - TLC, DLC, SPAG, c/s if indicated&#xD;
  &#xD;
               9. Day - 60, Day - 90 (end of follow-up)&#xD;
  &#xD;
              10. Blood : KFT, LFT, CBC, INR, AFP&#xD;
  &#xD;
              11. Imaging : USG abdomen, X-ray chest, 2D ECHO&#xD;
  &#xD;
          -  STATISTICAL ANALYSIS -&#xD;
  &#xD;
               1. Data will be reported as mean + SD.&#xD;
  &#xD;
               2. Categorical variables will be compared using the chi-square test or Fisher exact&#xD;
                  test&#xD;
  &#xD;
               3. Normal continuous variables will be compared using the Student's t test&#xD;
  &#xD;
               4. Non normal continuous variables will be compared using the Mann-Whitney rank-sum&#xD;
                  test (unpaired data) or the Wilcoxon test (paired data).&#xD;
  &#xD;
               5. The actuarial probability of survival will be calculated by the Kaplan-Meier method&#xD;
                  and compared using the log-rank test.&#xD;
  &#xD;
               6. A Cox regression analysis will be performed to identify independent prognostic&#xD;
                  factors for survival.&#xD;
  &#xD;
               7. Univariate and multivariate analysis will be used whenever applicable.&#xD;
  &#xD;
          -  Adverse effects - Chest pain, pain at the site, Breathlessness, infection, pneumothorax,&#xD;
             infection, bleeding&#xD;
  &#xD;
          -  Stopping rule -&#xD;
  &#xD;
               1. Liver Transplant&#xD;
  &#xD;
               2. Appearance of SBP, PICD, HE.&#xD;
  &#xD;
               3. Mortality&#xD;
  &#xD;
               4. End of follow-up&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">February 27, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 27, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Frequency of Repeated Thoracocentesis</measure>
      <time_frame>Day 30</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Frequency of Repeated Thoracocentesis</measure>
      <time_frame>Day 90</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of refilling hydrothorax within</measure>
      <time_frame>72 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of Repeated Thoracocentesis.</measure>
      <time_frame>Day 30 and Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of Complete Response, Partial Response, No response.</measure>
      <time_frame>Day 7, Day 30, Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of times Thoracocentesis is required between both groups at Day 30</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of times Thoracocentesis is required between both groups at Day 90</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 7</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 30</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 90</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Renal parameters - Serum Creatinine at Day 7</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Renal parameters - Serum Creatinine at Day 30</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Renal parameters - Serum Creatinine at Day 90</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepatic encephalopathy: Grading as per West Haven Classification.</measure>
      <time_frame>Day 7</time_frame>
      <description>West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepatic encephalopathy: Grading as per West Haven Classification.</measure>
      <time_frame>Day 30</time_frame>
      <description>West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepatic encephalopathy: Grading as per West Haven Classification.</measure>
      <time_frame>Day 90</time_frame>
      <description>West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants developing Na &lt; 120 meg/l Day 7</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants developing Na &lt; 120 meg/l Day 30</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants developing Na &lt; 120 meg/l Day 90</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dose of Diuretic in each arm Day 7</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dose of Diuretic in each arm Day 30</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dose of Diuretic in each arm Day 90</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 7</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 30</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 90</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients developing Spontaneous Bacterial Empyema Day 7</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients developing Spontaneous Bacterial Empyema Day 30</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients developing Spontaneous Bacterial Empyema Day 90</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>No. of days pateint surviving without Liver transplant and TIPS at Day 7</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>No. of days pateint surviving without Liver transplant and TIPS at Day 30</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>No. of days pateint surviving without Liver transplant and TIPS at Day 90</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Post procedure complications in between both groups at Day 7</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Post procedure complications in between both groups at Day 30</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of Post procedure complications in between both groups at Day 90</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in MELD between the groups</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in MELD between the groups</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in MELD between the groups</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in CTP between the groups</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in CTP between the groups</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in CTP between the groups</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Episodes of Hospitalization between both groups at Day 7</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Episodes of Hospitalization between both groups at Day 30</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Episodes of Hospitalization between both groups at Day 90</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative dose of albumin at D7 in two groups</measure>
      <time_frame>Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative dose of albumin at D30 in two groups</measure>
      <time_frame>Day 30</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cumulative dose of albumin at D90 in two groups</measure>
      <time_frame>Day 90</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Hepatic Hydrothorax</condition>
    <arm_group>
      <arm_group_label>Large Volume Thoracocentesis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group 1 - on-demand therapeutic thoracocentensis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pigtail Catheter</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group 2 - small volume frequent thoracocentesis using PCD</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Large Volume Thoracocentesis</intervention_name>
      <description>Large Volume Thoracocentesis</description>
      <arm_group_label>Large Volume Thoracocentesis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Pigtail Catheter</intervention_name>
      <description>Pigtail Catheter</description>
      <arm_group_label>Pigtail Catheter</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-75 years&#xD;
  &#xD;
            2. CLD with refilling symptomatic hepatic hydrothorax&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. CTP &gt;12, MELD&gt;25&#xD;
  &#xD;
            2. Tubercular PE, Ischemic cardiac disease&#xD;
  &#xD;
            3. If opting for TIPS/ LT&#xD;
  &#xD;
            4. Severe HPS&#xD;
  &#xD;
            5. Prior or current SBE/ SBP, septic shock&#xD;
  &#xD;
            6. Patients on mechanical ventilator&#xD;
  &#xD;
            7. Serum Creatinine &gt;2 mg/dl&#xD;
  &#xD;
            8. Extrahepatic malignancy&#xD;
  &#xD;
            9. Serum Sodium &lt; 120&#xD;
  &#xD;
           10. Post TIPS/ BRTO/ SAE patients&#xD;
  &#xD;
           11. Post renal or liver transplantation&#xD;
  &#xD;
           12. Lack of informed consent&#xD;
  &#xD;
           13. Hepatocellular carcinoma outside milan criteria&#xD;
  &#xD;
           14. Non-cirrhotic portal HT&#xD;
  &#xD;
           15. Known HIV infection&#xD;
  &#xD;
           16. Pregnant women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dr Jaifrin Daniel, MD</last_name>
      <phone>01146300000</phone>
      <email>jdaniel.m07@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Institute of Liver &amp; Biliary Sciences</name>
        <address>
          <city>New Delhi</city>
          <state>Delhi</state>
          <zip>110070</zip>
          <country>India</country>
        </address>
      </facility>
      <contact>
        <last_name>Dr . Jaifrin Daniel, MD</last_name>
        <phone>01146300000</phone>
        <email>jdaniel.m07@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hydrothorax</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06007820
  org study id: ILBS-Cirrhosis-60
  nct id: NCT06007820
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  -  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
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Frequency of Repeated Thoracocentesis
  time frame: Day 30
  measure: Frequency of Repeated Thoracocentesis
  time frame: Day 90
  measure: Incidence of refilling hydrothorax within
  time frame: 72 hours
  measure: Frequency of Repeated Thoracocentesis.
  time frame: Day 30 and Day 90
  measure: Rate of Complete Response, Partial Response, No response.
  time frame: Day 7, Day 30, Day 90
  measure: Number of times Thoracocentesis is required between both groups at Day 30
  time frame: Day 30
  measure: Number of times Thoracocentesis is required between both groups at Day 90
  time frame: Day 90
  measure: Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 7
  time frame: Day 7
  measure: Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 30
  time frame: Day 30
  measure: Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 90
  time frame: Day 90
  measure: Change in Renal parameters - Serum Creatinine at Day 7
  time frame: Day 7
  measure: Change in Renal parameters - Serum Creatinine at Day 30
  time frame: Day 30
  measure: Change in Renal parameters - Serum Creatinine at Day 90
  time frame: Day 90
  measure: Hepatic encephalopathy: Grading as per West Haven Classification.
  time frame: Day 7
  description: West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.
  measure: Hepatic encephalopathy: Grading as per West Haven Classification.
  time frame: Day 30
  description: West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.
  measure: Hepatic encephalopathy: Grading as per West Haven Classification.
  time frame: Day 90
  description: West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.
  measure: Proportion of participants developing Na < 120 meg/l Day 7
  time frame: Day 7
  measure: Proportion of participants developing Na < 120 meg/l Day 30
  time frame: Day 30
  measure: Proportion of participants developing Na < 120 meg/l Day 90
  time frame: Day 90
  measure: Dose of Diuretic in each arm Day 7
  time frame: Day 7
  measure: Dose of Diuretic in each arm Day 30
  time frame: Day 30
  measure: Dose of Diuretic in each arm Day 90
  time frame: Day 90
  measure: Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 7
  time frame: Day 7
  measure: Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 30
  time frame: Day 30
  measure: Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 90
  time frame: Day 90
  measure: Proportion of patients developing Spontaneous Bacterial Empyema Day 7
  time frame: Day 7
  measure: Proportion of patients developing Spontaneous Bacterial Empyema Day 30
  time frame: Day 30
  measure: Proportion of patients developing Spontaneous Bacterial Empyema Day 90
  time frame: Day 90
  measure: No. of days pateint surviving without Liver transplant and TIPS at Day 7
  time frame: Day 7
  measure: No. of days pateint surviving without Liver transplant and TIPS at Day 30
  time frame: Day 30
  measure: No. of days pateint surviving without Liver transplant and TIPS at Day 90
  time frame: Day 90
  measure: Incidence of Post procedure complications in between both groups at Day 7
  time frame: Day 7
  measure: Incidence of Post procedure complications in between both groups at Day 30
  time frame: Day 30
  measure: Incidence of Post procedure complications in between both groups at Day 90
  time frame: Day 90
  measure: Changes in MELD between the groups
  time frame: Day 7
  measure: Changes in MELD between the groups
  time frame: Day 30
  measure: Changes in MELD between the groups
  time frame: Day 90
  measure: Changes in CTP between the groups
  time frame: Day 7
  measure: Changes in CTP between the groups
  time frame: Day 30
  measure: Changes in CTP between the groups
  time frame: Day 90
  measure: Number of Episodes of Hospitalization between both groups at Day 7
  time frame: Day 7
  measure: Number of Episodes of Hospitalization between both groups at Day 30
  time frame: Day 30
  measure: Number of Episodes of Hospitalization between both groups at Day 90
  time frame: Day 90
  measure: Cumulative dose of albumin at D7 in two groups
  time frame: Day 7
  measure: Cumulative dose of albumin at D30 in two groups
  time frame: Day 30
  measure: Cumulative dose of albumin at D90 in two groups
  time frame: Day 90
  arm group label: Large Volume Thoracocentesis
  arm group type: Experimental
  description: Group 1 - on-demand therapeutic thoracocentensis
  arm group label: Pigtail Catheter
  arm group type: Active Comparator
  description: Group 2 - small volume frequent thoracocentesis using PCD
  intervention type: Procedure
  intervention name: Large Volume Thoracocentesis
  description: Large Volume Thoracocentesis
  arm group label: Large Volume Thoracocentesis
  intervention type: Procedure
  intervention name: Pigtail Catheter
  description: Pigtail Catheter
  arm group label: Pigtail Catheter
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Dr Jaifrin Daniel, MD
  phone: 01146300000
  email: jdaniel.m07@gmail.com
  facility: 
  contact: 
  country: India
  responsible party type: Sponsor
  mesh term: Hydrothorax