Efficacy & Safety of Pigtail Catheter Drainage Versus Need Based Thoracocentesis for Recurrent Hepatic Hydrothorax.
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2023
CompletedStudy Start
First participant enrolled
August 15, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2024
CompletedAugust 23, 2023
August 1, 2023
7 months
August 5, 2023
August 18, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Frequency of Repeated Thoracocentesis
Day 30
Frequency of Repeated Thoracocentesis
Day 90
Secondary Outcomes (44)
Incidence of refilling hydrothorax within
72 hours
Frequency of Repeated Thoracocentesis.
Day 30 and Day 90
Rate of Complete Response, Partial Response, No response.
Day 7, Day 30, Day 90
Number of times Thoracocentesis is required between both groups at Day 30
Day 30
Number of times Thoracocentesis is required between both groups at Day 90
Day 90
- +39 more secondary outcomes
Study Arms (2)
Large Volume Thoracocentesis
EXPERIMENTALGroup 1 - on-demand therapeutic thoracocentensis
Pigtail Catheter
ACTIVE COMPARATORGroup 2 - small volume frequent thoracocentesis using PCD
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-75 years
- CLD with refilling symptomatic hepatic hydrothorax
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2023
First Posted
August 23, 2023
Study Start
August 15, 2023
Primary Completion
February 27, 2024
Study Completion
February 27, 2024
Last Updated
August 23, 2023
Record last verified: 2023-08