Clinical trial NCT06007820: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepatic Hydrothorax
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of Repeated Thoracocentesis
timeFrame: Day 30
measure: Frequency of Repeated Thoracocentesis
timeFrame: Day 90
Secondary outcomes:
measure: Incidence of refilling hydrothorax within
timeFrame: 72 hours
measure: Frequency of Repeated Thoracocentesis.
timeFrame: Day 30 and Day 90
measure: Rate of Complete Response, Partial Response, No response.
timeFrame: Day 7, Day 30, Day 90
measure: Number of times Thoracocentesis is required between both groups at Day 30
timeFrame: Day 30
measure: Number of times Thoracocentesis is required between both groups at Day 90
timeFrame: Day 90
measure: Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 7
timeFrame: Day 7
measure: Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 30
timeFrame: Day 30
measure: Proportion of pateint developing Post thoracocentesis Shock (Change in Heart Rate, Blood pressure) at Day 90
timeFrame: Day 90
measure: Change in Renal parameters - Serum Creatinine at Day 7
timeFrame: Day 7
measure: Change in Renal parameters - Serum Creatinine at Day 30
timeFrame: Day 30
measure: Change in Renal parameters - Serum Creatinine at Day 90
timeFrame: Day 90
measure: Hepatic encephalopathy: Grading as per West Haven Classification.
timeFrame: Day 7
measure: Hepatic encephalopathy: Grading as per West Haven Classification.
timeFrame: Day 30
measure: Hepatic encephalopathy: Grading as per West Haven Classification.
timeFrame: Day 90
measure: Proportion of participants developing Na < 120 meg/l Day 7
timeFrame: Day 7
measure: Proportion of participants developing Na < 120 meg/l Day 30
timeFrame: Day 30
measure: Proportion of participants developing Na < 120 meg/l Day 90
timeFrame: Day 90
measure: Dose of Diuretic in each arm Day 7
timeFrame: Day 7
measure: Dose of Diuretic in each arm Day 30
timeFrame: Day 30
measure: Dose of Diuretic in each arm Day 90
timeFrame: Day 90
measure: Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 7
timeFrame: Day 7
measure: Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 30
timeFrame: Day 30
measure: Proportion of patient developing Spontaneous Bacterial Peritonitis at Day 90
timeFrame: Day 90
measure: Proportion of patients developing Spontaneous Bacterial Empyema Day 7
timeFrame: Day 7
measure: Proportion of patients developing Spontaneous Bacterial Empyema Day 30
timeFrame: Day 30
measure: Proportion of patients developing Spontaneous Bacterial Empyema Day 90
timeFrame: Day 90
measure: No. of days pateint surviving without Liver transplant and TIPS at Day 7
timeFrame: Day 7
measure: No. of days pateint surviving without Liver transplant and TIPS at Day 30
timeFrame: Day 30
measure: No. of days pateint surviving without Liver transplant and TIPS at Day 90
timeFrame: Day 90
measure: Incidence of Post procedure complications in between both groups at Day 7
timeFrame: Day 7
measure: Incidence of Post procedure complications in between both groups at Day 30
timeFrame: Day 30
measure: Incidence of Post procedure complications in between both groups at Day 90
timeFrame: Day 90
measure: Changes in MELD between the groups
timeFrame: Day 7
measure: Changes in MELD between the groups
timeFrame: Day 30
measure: Changes in MELD between the groups
timeFrame: Day 90
measure: Changes in CTP between the groups
timeFrame: Day 7
measure: Changes in CTP between the groups
timeFrame: Day 30
measure: Changes in CTP between the groups
timeFrame: Day 90
measure: Number of Episodes of Hospitalization between both groups at Day 7
timeFrame: Day 7
measure: Number of Episodes of Hospitalization between both groups at Day 30
timeFrame: Day 30
measure: Number of Episodes of Hospitalization between both groups at Day 90
timeFrame: Day 90
measure: Cumulative dose of albumin at D7 in two groups
timeFrame: Day 7
measure: Cumulative dose of albumin at D30 in two groups
timeFrame: Day 30
measure: Cumulative dose of albumin at D90 in two groups
timeFrame: Day 90
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
References: