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

NCT ID: NCT06007820

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2024-02-27

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

Conditions

Hepatic Hydrothorax

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Large Volume Thoracocentesis

Group 1 - on-demand therapeutic thoracocentensis

Group Type: EXPERIMENTAL

Large Volume Thoracocentesis

Intervention Type: PROCEDURE

Large Volume Thoracocentesis

Pigtail Catheter

Group 2 - small volume frequent thoracocentesis using PCD

Group Type: ACTIVE_COMPARATOR

Pigtail Catheter

Intervention Type: PROCEDURE

Pigtail Catheter

Interventions

Large Volume Thoracocentesis

Large Volume Thoracocentesis

Intervention Type: PROCEDURE

Pigtail Catheter

Pigtail Catheter

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Central Contacts

Dr Jaifrin Daniel, MD

Role: CONTACT

jdaniel.m07@gmail.com

01146300000

Facility Contacts

Dr . Jaifrin Daniel, MD

Role: primary

jdaniel.m07@gmail.com

01146300000

Other Identifiers

ILBS-Cirrhosis-60

Identifier Type: -

Identifier Source: org_study_id