To assess whether it is safe and outcome of drainage of fluid in the lungs of patients with cirrhosis.

“Efficacy & safety of pigtail catheter drainage versus large volume Need based thoracocentesis for recurrent hepatic hydrothorax. A randomized controlled trial. - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057708

Enrollment

Registered

2023-09-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: Large Volume Thoracocentesis - 1000 ml: on-demand large volume therapeutic thoracocentensis in patients who a clinically symptomatic Duration: 7 Days Control Intervention1: Pigtail Cath

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years 2. CLD with refilling symptomatic hepatic hydrothorax

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
No of patients requiring repeated thoracocentesis in both armsTimepoint: Day 30 & 90	—

Secondary

Measure	Time frame
AKI : Improvement or worsening of renal functionsTimepoint: Day 7, Day 30, Day 90;Bacterial Empyema/ peritonitis : Pleural/ Ascitic fluid neutrophil count 250 cells/cu. mm.Timepoint: Day 7, Day 30, Day 90;Changes in Model for End-Stage for Liver Disease or Child-Turcotte-Pugh between the groups.Timepoint: Day 7, Day 30, Day 90;Cumulative dose of albumin at D7 in two groups.Timepoint: Day 7, Day 30, Day 90;Diuretic tolerability: Dose & duration tolerated.Timepoint: Day 7, Day 30, Day 90;Frequency of Repeated ThoracocentesisTimepoint: Day 30 & Day 90;Hepatic encephalopathy: Grading as per West Haven ClassificationTimepoint: Day 7, Day 30, Day 90;Incidence of refilling hydrothorax withinTimepoint: 72 hours;Moderate-severe Hyponatremia (Na 120meq/L)Timepoint: Day 7, Day 30, Day 90;Need for hospitalization between the groupsTimepoint: Day 7, Day 30, Day 90;Need for repeated Single Time Aspiration.Timepoint: Day 30 & Day 90;Proportion developing Post Paracentesis Circulatory DysfunctionTimepoint: Day 7, Day 30, Day 90;Rate of Complete Response, Partial Response, No responseTimepoint: Day 7, Day 30, Day 90;Risk of procedure related complications (Pneumothorax, hydro pneumothorax, bleed)Timepoint: Day 7, Day 30, Day 90;Transplant & TIPS free survivalTimepoint: Day 7, Day 30, Day 90	—

Measure

Time frame

AKI : Improvement or worsening of renal functionsTimepoint: Day 7, Day 30, Day 90;Bacterial Empyema/ peritonitis : Pleural/ Ascitic fluid neutrophil count 250 cells/cu. mm.Timepoint: Day 7, Day 30, Day 90;Changes in Model for End-Stage for Liver Disease or Child-Turcotte-Pugh between the groups.Timepoint: Day 7, Day 30, Day 90;Cumulative dose of albumin at D7 in two groups.Timepoint: Day 7, Day 30, Day 90;Diuretic tolerability: Dose & duration tolerated.Timepoint: Day 7, Day 30, Day 90;Frequency of Repeated ThoracocentesisTimepoint: Day 30 & Day 90;Hepatic encephalopathy: Grading as per West Haven ClassificationTimepoint: Day 7, Day 30, Day 90;Incidence of refilling hydrothorax withinTimepoint: 72 hours;Moderate-severe Hyponatremia (Na 120meq/L)Timepoint: Day 7, Day 30, Day 90;Need for hospitalization between the groupsTimepoint: Day 7, Day 30, Day 90;Need for repeated Single Time Aspiration.Timepoint: Day 30 & Day 90;Proportion developing Post Paracentesis Circulatory DysfunctionTimepoint: Day 7, Day 30, Day 90;Rate of Complete Response, Partial Response, No responseTimepoint: Day 7, Day 30, Day 90;Risk of procedure related complications (Pneumothorax, hydro pneumothorax, bleed)Timepoint: Day 7, Day 30, Day 90;Transplant & TIPS free survivalTimepoint: Day 7, Day 30, Day 90

—

Countries

India

Contacts

Public ContactDr Ankur Jindal

Institute of Liver and Biliary Sciences

ankur.jindal3@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026