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Benefit of early drainage of free fluid in abdomen in patients with severe acute pancreatitis as compared to no drainage

Early paracentesis in moderate to severe acute pancreatitis (EPISAP trial): a randomized controlled trial - EPISAP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086977
Enrollment
38
Registered
2025-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: K859- Acute pancreatitis, unspecified

Interventions

Intervention1: Early paracentesis: Early paracentesis group will undergo placement of a 8-10 Fr catheter (Malecot/pigtail) as appropriate under ultrasound guidance using Seldinger technique. The amoun

Sponsors

SGPGI intramural grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with moderately severe and severe AP presenting within 2 weeks of onset of pain Ascitic fluid pocket more than 100 mL and amenable to drainage by radiologist

Exclusion criteria

Exclusion criteria: 1. Patients without drainable ascites 2. Chronic pancreatitis 3. Cirrhosis 4. Coagulopathy as defined by INR more than 1.5 and platelets less than 1.5 lacs per mm3 5. Age less than 18 years of more than 75 years 6. Pregnant patients 7. Denial of consent 8. Abdominal compartment syndrome defined by IAP more than 20 mm Hg with organ failure as per World Society of Abdominal Compartment Syndrome criteria (WSACS)

Design outcomes

Secondary

MeasureTime frame
Secondary outcome: 1. intraabdominal pressure at day 7 of randomization 2. Prevalence of SIRS between two groups on day 7 3. No of organ failures at day 7 4.Hospital stay (days) 5.Development of IPN at day 30 6. MortalityTimepoint: day 7 and day 30

Primary

MeasureTime frame
Interleukin-6 levels at 1 weekTimepoint: Interleukin-6 levels at 1 week

Countries

India

Contacts

Public ContactAnshuman Elhence

Sanjay Gandhi Post Graduate Institute of Medical Sciences

anshu27790@gmail.com8587935706

Outcome results

None listed

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