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Study on Tocilizumab in Patients with Predicted Severe Acute Pancreatitis (STOP-SAP) for Preventing Progression to Actual Severe Acute Pancreatitis: A Randomized, Double-Blind, Placebo-Controlled Trial

Study on Tocilizumab in Patients with Predicted Severe Acute Pancreatitis (STOP-SAP) for Preventing Progression to Actual Severe Acute Pancreatitis: A Randomized, Double-Blind, Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210302008
Enrollment
50
Registered
2021-03-02
Start date
2021-03-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

predicted severe acute pancreatitis severe acute pancreatitis

Interventions

Standard treatment and Tocilizumab 4 mg/kg IV *1 dose ,Standard treatment and NSS 100 ml IV drip
Experimental Drug,Placebo Comparator No treatment
Tocilizumab,placebo

Sponsors

Chulalongkorn University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Predicted severe acute pancreatitis at admission, defined by at least one of 1. BISAP equal or more than 3 2. End organ failures by Modified Marshall scoring system

Exclusion criteria

Exclusion criteria: ALT or AST > 5x UNL onset of pancreatitis more than 72 hours severe acute pancreatitis at admission Severe cholangitis Chronic pancreatitis Cardiomyopathy (EF < 30) or active heart failure Active/uncontrolled infection Terminal cancer Hypersensitivity Previous treatment with tocilizumab Pregnancy Inability or unwillingness to provide consent

Design outcomes

Primary

MeasureTime frame
Actual severe acute pancreatitis 48 hour after admission Defined by Revised Atlanta Classification

Secondary

MeasureTime frame
mortality rate in admission death,adverse event rate in admission adverse event rate,length of hospital stay in admission day,length of ICU stay in admission day,local complication in admission Defined by Revised Atlanta classification

Countries

Thailand

Contacts

Public ContactParit Mekaroonkamol

Chulalongkorn University

mekaropa@gmail.com022564256

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026