Safety and Efficacy of Small Frequent Paracentesis Using an Indwelling CAtheter Compared With Repeated Large Volume Paracentesis in Cirrhotic Patients With REfractory Ascites

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Liver Cirrhosis

Treatments: Procedure: Large Volume Paracentesis; Procedure: small quantity paracentesis

Study type: Interventional

Funder types: Other

Identifiers

NCT04406298

ILBS-Cirrhosis-29

Details and patient eligibility

About

The aim of the study is to assess the efficacy of intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days in comparison with large volume paracentesis on decreasing the need for repeated paracentesis by 50 % over next 3 months. The project will be conducted at ILBS between April 2020 and March 2021. The concept of the study is to evaluate the efficacy of indwelling catheter in reducing the refilling rates of ascites by 50 % over 3 months in comparison to LVPs and also in reducing the incidence and risk of PPCD. All refractory ascites patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives.

The expected outcomes are

Primary outcome: Proportion of cirrhotic patients with refractory ascites achieving at least 50 % reduction on need for large volume paracentesis after a short duration (5day) intermittent small quantity (up to 3L/ day) paracentesis through an indwelling catheter in comparison to a single large volume paracentesis in the next 3 months.

Secondary outcome:

1. Proportion of cirrhotic patients with refractory ascites developing P 2 . During a 30 D, 60 D and 90 D follow up, to assess between the groups

• Need for repeated paracentesis : Number assessed
• AKI : Improvement or worsening of renal functions
• Hepatic encephalopathy: Grading as per West Haven Classification
• Hyponatremia
• Diuretic tolerability : Dose and duration tolerated
• Bacterial peritonitis : Ascitic fluid neutrophil count > 250 cells/cumm
• Transplant free survival
• Risk of procedure related complications
• Changes in MELD or CTP between the groups ( Improvement vs worsening )
• Need for hospitalization between the groups

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cirrhotic patients 18-70 yrs with refractory severe ascites with stable renal function (S.creatinine < 2 mg/dl).

Exclusion criteria

• CTP >12, MELD>25
• Prior or current Spontaneous Bacterial Peritonitis (SBP)
• Recurrent or current overt hepatic encephalopathy
• Serum Creatinine >2
• HVOTO (Hepatic Venous Outflow Tract Obstruction)
• Hepatic or extrahepatic malignancy
• Recent UGI bleed
• Sepsis
• Serum Sodium < 120

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Small Quantity Paracentesis

Experimental group

Description:

Intermittent small quantity (upto 3L per day) paracentesis through an indwelling catheter for up to 5 days.

Treatment:

Procedure: small quantity paracentesis

Large Volume Paracentesis

Active Comparator group

Description:

Large Volume Paracentesis \> 5 litres

Treatment:

Procedure: Large Volume Paracentesis