FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080458 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Steroid therapy for organ failure in acute pancreatitis 
Scientific Title of Study   Steroid therapy in patients with acute severe pancreatitis for resolution of organ failure: A randomized, controlled, double blinded trial  
Trial Acronym  STAR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Soumya Jagannath Mahapatra 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, new Delhi 
Address  3106, Third floor, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9990420767  
Fax    
Email  soumyajagannath@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Soumya Jagannath Mahapatra 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, new Delhi 
Address  3106, Third floor, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9990420767  
Fax    
Email  soumyajagannath@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Soumya Jagannath Mahapatra 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, new Delhi 
Address  3106, Third floor, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  9990420767  
Fax    
Email  soumyajagannath@yahoo.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar East, New Delhi, India 110029 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari Nagar, New Delhi, 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemanta Kumar Nayak  All India Institute of Medical Sciences  Department of Gastroenterology, Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA 		 7008927243

drhemantnayak@gmail.com 
Dr Soumya Jagannath Mahapatra  All India Institute of Medical Sciences  3106, Third floor, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi
South
DELHI 		 9990420767

soumyajagannath@yahoo.com 
Dr Sudipta Dhar Chowdhury  Christian Medical College  Department of Gastroenterology, Ida Scudder Road
Vellore
TAMIL NADU 		 9952311988

sudiptadharchowdhury@gmail.com 
Dr Siddharth Srivastava  Maulana Azad Medical College and G B Pant Hospital  Department of Gastroenterology
New Delhi
DELHI 		 9718599215

docsiddharth1@gmail.com 
Dr Jayanta Samanta  Postgraduate Institute of Medical Education and Research  Department of Gastroenterology, Sector-12
Chandigarh
CHANDIGARH 		 9855319529

dj_samanta@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, Bhubaneswar   Approved 
Institute Ethics Committee, PGIMER, Chandigarh  Approved 
Institutional Ethics Committee, AIIMS, Delhi  Approved 
Institutional Ethics committee, Christan Medical College, Vellore  Approved 
Institutional Ethics Committee, G.B Pant Hospital, Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K85||Acute pancreatitis,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Injection Methyl prednisolone (MPS) Intravenous  Intravenous methyl prednisolone MPS 60 mg for first 3 days, 40 mg for next 2 days, and subsequent taper over next 3-5 days depending upon clinical response (if there is no response, 30 mg for day 6 and 20 mg for day 7 and 10mg for day 8; if there is response, then 30 mg for next 2 days followed by 20 mg for next day7, 15mg for day 8, 10 mg for day 9 and 5mg for day 10). 
Comparator Agent  Placebo  Identical looking Placebo will be provided as same route, dose and duration described for the drug. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Diagnosis of Acute Pancreatitis as per revised Atlanta Classification.
2. Patients presenting within seven days of onset of pain.
3. Presence of any organ failure (Modified Marshal grade greater than or equal to 2) i.e. cardiovascular, respiratory or renal and APACHE II score greater than or equal to 8 or systemic inflammatory response syndrome greater than 24 hours (SIRS should be assessed at two time points greater than 6 hours apart) or BISAP score greater than 3. 
 
ExclusionCriteria 
Details  1. Patients with Chronic Pancreatitis
2. Pregnancy and breast feeding
3. Age less than 12 years or greater than 75 years
4. Major comorbidity such as decompensated cirrhosis, Advanced heart failure (stage D), significant lung parenchymal or airway disease with NYHA grade greater than or equal to 3, advanced chronic kidney disease (stage greater than or equal to 4), untreated HIV infection, untreated cancer.
5. Patient already on immune-suppressive therapy
6. Major psychiatry disorders such as psychosis, schizophrenia, major depression, bipolar disorder etc.
7. Uncontrolled diabetes (HbA1C greater than 8), uncontrolled hypertension (systolic blood pressure greater than or equal to 140 mm Hg and diastolic blood pressure greater than or equal to 90 mm Hg as per eighth joint national committee criteria)
8. Brain dead patient or patients with two organ failure (each grade
9. Acute cholecystitis
10. Active tuberculosis
11. Known adrenal insufficiency
12. Acute gastrointestinal bleed within last 7 days
13. Presence of disseminated intravascular coagulation (DIC)
14. Encephalopathy as defined by Glassgow Coma scale less than or equal to 9.

 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time of resolution of organ failure within 28 days from randomization. Resolution will be defined as Modified Marshall score of one or less.  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Organ Failure resolution  28 days 
All Cause mortality  4 weeks 
Resolution of cytokine storm syndrome  4 weeks 
Need for mechanical ventilation or hemodialysis  4 weeks 
Duration of ICU stay  4 weeks 
Development of infected necrosis  3 months 
Need for drainage of collection  3 months 
Need for necrosectomy  3 months 
Adverse events  28 days 
 
Target Sample Size   Total Sample Size="202"
Sample Size from India="202" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   21/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [soumyajagannath@yahoo.com].

  6. For how long will this data be available start date provided 31-03-2025 and end date provided 31-03-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NO
Brief Summary
Modification(s)  

Rationale: Severe acute pancreatitis (SAP) is associated with organ failure, and the 28-day mortality may be as high as 25-30%. Dysregulated immune response and systemic inflammation are implicated in its pathogenesis. Currently, there is no approved therapy to control systemic hyperinflammation, and the management is largely supportive. 

Novelty: Steroid therapy has the potential for controlling dysregulated immune response with a reduction of systemic inflammation in SAP. Experimental studies, including our own, have shown improvement in organ failure with steroid therapy in the SAP animal model. A Phase 2 pilot study of steroid therapy for SAP in humans has demonstrated improvement in organ failure without untoward adverse events. 

Objective: To compare the time for resolution of organ failure with steroid therapy compared to placebo in patients with SAP and ongoing organ failure.

Methods: It will be a multicenter, randomized, double-blind, placebo-controlled trial. Patients with SAP and ongoing organ failure (Marshall score of 2 or more) will be included in the study. They will be randomized to receive either intravenous methyl prednisolone 64 mg or an identical-looking placebo in addition to standard of care and will be tapered over 10 days depending upon the clinical response. Time to resolution of the organ failure will be the primary outcome. Adverse events, 30-day mortality, resolution of cytokine storm syndrome, hospital stay, and development of infected pancreatic necrosis will be secondary outcomes.

Expected Outcome: Steroid therapy might emerge as a treatment option for SAP and ongoing organ failure.

 

 
Close