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

Primary Purpose

Hepatic Hydrothorax

Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Large Volume Thoracocentesis
Pigtail Catheter
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Hydrothorax

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-75 years CLD with refilling symptomatic hepatic hydrothorax Exclusion Criteria: CTP >12, MELD>25 Tubercular PE, Ischemic cardiac disease If opting for TIPS/ LT Severe HPS 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

Sites / Locations

  • Institute of Liver & Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Large Volume Thoracocentesis

Pigtail Catheter

Arm Description

Group 1 - on-demand therapeutic thoracocentensis

Group 2 - small volume frequent thoracocentesis using PCD

Outcomes

Primary Outcome Measures

Frequency of Repeated Thoracocentesis
Frequency of Repeated Thoracocentesis

Secondary Outcome Measures

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

Full Information

First Posted
August 5, 2023
Last Updated
August 18, 2023
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT06007820
Brief Title
Efficacy & Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax.
Official Title
Efficacy & Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
February 27, 2024 (Anticipated)
Study Completion Date
February 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 Etiology of cirrhosis Severity of ascites, Jaundice Prior Hepatic encephalopathy, bleed, Jaundice Prior Spontaneous bacterial peritonitis, large volume paracentesis frequency Pattern and number of prior decompensation Prior Acute on Chronic Liver Failure and Acute Kidney episodes Use of non selective beta blockers, norfloxaxin, rifaximin and albumin History of Endoscopic Variceal ligation or other endotherapy History of Hypertension, Diabetes Fever , signs of sepsis (SIRS) 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 Complications - SBP, SBE, ACLF and Jaundice, HE/ AKI episodes HTN, Diabetes control Fever , signs of sepsis (SIRS) 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) - Blood : KFT, LFT, CBC, INR, AFP, PCT, S.PRA, Pro-BNP, Urinary Na Imaging : USG abdomen, X-ray chest, 2D ECHO Pleural fluid/ ascitic fluid - TLC, DLC, Protein, Sugar, SPAG, SAAG, ADA, c/s Hemodynamics : Intrapleural pressures at first TT Baseline (at randomization, Day -3 and Day - 7 in PCD-TT) - Blood : KFT, INR; S.PRA, Pro-BNP, Urinary Na (at Day 7) Imaging : X-ray chest Pleural fluid/ ascitic fluid - TLC, DLC, SPAG, c/s if indicated Day - 60, Day - 90 (end of follow-up) Blood : KFT, LFT, CBC, INR, AFP Imaging : USG abdomen, X-ray chest, 2D ECHO STATISTICAL ANALYSIS - Data will be reported as mean + SD. Categorical variables will be compared using the chi-square test or Fisher exact test Normal continuous variables will be compared using the Student's t test Non normal continuous variables will be compared using the Mann-Whitney rank-sum test (unpaired data) or the Wilcoxon test (paired data). The actuarial probability of survival will be calculated by the Kaplan-Meier method and compared using the log-rank test. A Cox regression analysis will be performed to identify independent prognostic factors for survival. Univariate and multivariate analysis will be used whenever applicable. Adverse effects - Chest pain, pain at the site, Breathlessness, infection, pneumothorax, infection, bleeding Stopping rule - Liver Transplant Appearance of SBP, PICD, HE. Mortality End of follow-up

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Hydrothorax

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Large Volume Thoracocentesis
Arm Type
Experimental
Arm Description
Group 1 - on-demand therapeutic thoracocentensis
Arm Title
Pigtail Catheter
Arm Type
Active Comparator
Arm Description
Group 2 - small volume frequent thoracocentesis using PCD
Intervention Type
Procedure
Intervention Name(s)
Large Volume Thoracocentesis
Intervention Description
Large Volume Thoracocentesis
Intervention Type
Procedure
Intervention Name(s)
Pigtail Catheter
Intervention Description
Pigtail Catheter
Primary Outcome Measure Information:
Title
Frequency of Repeated Thoracocentesis
Time Frame
Day 30
Title
Frequency of Repeated Thoracocentesis
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Incidence of refilling hydrothorax within
Time Frame
72 hours
Title
Frequency of Repeated Thoracocentesis.
Time Frame
Day 30 and Day 90
Title
Rate of Complete Response, Partial Response, No response.
Time Frame
Day 7, Day 30, Day 90
Title
Number of times Thoracocentesis is required between both groups at Day 30
Time Frame
Day 30
Title
Number of times Thoracocentesis is required between both groups at Day 90
Time Frame
Day 90
Title
Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 7
Time Frame
Day 7
Title
Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 30
Time Frame
Day 30
Title
Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 90
Time Frame
Day 90
Title
Change in Renal parameters - Serum Creatinine at Day 7
Time Frame
Day 7
Title
Change in Renal parameters - Serum Creatinine at Day 30
Time Frame
Day 30
Title
Change in Renal parameters - Serum Creatinine at Day 90
Time Frame
Day 90
Title
Hepatic encephalopathy: Grading as per West Haven Classification.
Description
West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.
Time Frame
Day 7
Title
Hepatic encephalopathy: Grading as per West Haven Classification.
Description
West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.
Time Frame
Day 30
Title
Hepatic encephalopathy: Grading as per West Haven Classification.
Description
West Haven Grade (1-4) will be used to assess Hepatic Encephaloapthy, Grade 4 means worse outcome.
Time Frame
Day 90
Title
Proportion of participants developing Na < 120 meg/l Day 7
Time Frame
Day 7
Title
Proportion of participants developing Na < 120 meg/l Day 30
Time Frame
Day 30
Title
Proportion of participants developing Na < 120 meg/l Day 90
Time Frame
Day 90
Title
Dose of Diuretic in each arm Day 7
Time Frame
Day 7
Title
Dose of Diuretic in each arm Day 30
Time Frame
Day 30
Title
Dose of Diuretic in each arm Day 90
Time Frame
Day 90
Title
Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 7
Time Frame
Day 7
Title
Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 30
Time Frame
Day 30
Title
Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 90
Time Frame
Day 90
Title
Proportion of patients developing Spontaneous Bacterial Empyema Day 7
Time Frame
Day 7
Title
Proportion of patients developing Spontaneous Bacterial Empyema Day 30
Time Frame
Day 30
Title
Proportion of patients developing Spontaneous Bacterial Empyema Day 90
Time Frame
Day 90
Title
No. of days pateint surviving without Liver transplant and TIPS at Day 7
Time Frame
Day 7
Title
No. of days pateint surviving without Liver transplant and TIPS at Day 30
Time Frame
Day 30
Title
No. of days pateint surviving without Liver transplant and TIPS at Day 90
Time Frame
Day 90
Title
Incidence of Post procedure complications in between both groups at Day 7
Time Frame
Day 7
Title
Incidence of Post procedure complications in between both groups at Day 30
Time Frame
Day 30
Title
Incidence of Post procedure complications in between both groups at Day 90
Time Frame
Day 90
Title
Changes in MELD between the groups
Time Frame
Day 7
Title
Changes in MELD between the groups
Time Frame
Day 30
Title
Changes in MELD between the groups
Time Frame
Day 90
Title
Changes in CTP between the groups
Time Frame
Day 7
Title
Changes in CTP between the groups
Time Frame
Day 30
Title
Changes in CTP between the groups
Time Frame
Day 90
Title
Number of Episodes of Hospitalization between both groups at Day 7
Time Frame
Day 7
Title
Number of Episodes of Hospitalization between both groups at Day 30
Time Frame
Day 30
Title
Number of Episodes of Hospitalization between both groups at Day 90
Time Frame
Day 90
Title
Cumulative dose of albumin at D7 in two groups
Time Frame
Day 7
Title
Cumulative dose of albumin at D30 in two groups
Time Frame
Day 30
Title
Cumulative dose of albumin at D90 in two groups
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years CLD with refilling symptomatic hepatic hydrothorax Exclusion Criteria: CTP >12, MELD>25 Tubercular PE, Ischemic cardiac disease If opting for TIPS/ LT Severe HPS 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Jaifrin Daniel, MD
Phone
01146300000
Email
jdaniel.m07@gmail.com
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr . Jaifrin Daniel, MD
Phone
01146300000
Email
jdaniel.m07@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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