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CTRI Number  CTRI/2025/04/085322 [Registered on: 22/04/2025] Trial Registered Prospectively
Last Modified On: 22/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Serum D dimer and Procalcitonin Levels at Admission as Predictors of Severity in patients with Acute Pancreatitis  
Scientific Title of Study   Serum D-dimer and procalcitonin levels at admission as predictors of severity in acute pancreatitis: an observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Biswajit Naskar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Kalyani 
Address  Trauma & Emergency Medicine department, AIIMS Kalyani

Nadia
WEST BENGAL
741245
India 
Phone  6290074738  
Fax    
Email  mynameisjit310789@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Biswajit Naskar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Kalyani 
Address  Trauma & Emergency Medicine Department,AIIMS Kalyani,Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal

Nadia
WEST BENGAL
741245
India 
Phone  6290074738  
Fax    
Email  mynameisjit310789@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Biswajit Naskar 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences Kalyani 
Address  Trauma & Emergency Medicine Department, AIIMS Kalyani, Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal

Nadia
WEST BENGAL
741245
India 
Phone  6290074738  
Fax    
Email  mynameisjit310789@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Kalyani, Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Kalyani 
Address  Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Biswajit Naskar  All India Institute of Medical Sciences Kalyani  Department of Trauma & Emergency Medicine, Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL 
6290074738

mynameisjit310789@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K859||Acute pancreatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adult patients (18-70 years) with acute pancreatitis presenting within 24 hrs of symptom onset 
 
ExclusionCriteria 
Details  1. Pregnancy.
2. Patients presenting more than 24 hours of symptom onset.
3. Chronic pancreatitis
4. Recurrent pancreatitis
5. Age less than 18 years old or over 70 years old
6. Anticoagulant drug use
7. Cancer
8. Thrombotic diseases
9. Liver cirrhosis
10. Patient on immunosuppressive therapy
11. Refusal to give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To determine if serum D-dimer and procalcitonin levels at the time of admission can predict the severity of acute pancreatitis.
 

Preparation and ethical approval-1-2 months
Data collection- 3 months
Data analysis, reporting and dissemination:1 month
 
 
Secondary Outcome  
Outcome  TimePoints 
2.To evaluate whether D-dimer and procalcitonin levels are associated with the development of complications and mortality in patients with acute pancreatitis.
3.To determine the most reliable predictor between D-dimer and procalcitonin for early risk assessment in Acute Pancreatitis patients. 
Preparation and ethical approval-1-2 months
Data collection- 3 months
Data analysis, reporting and dissemination:1 month
 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   N/A 
Date of First Enrollment (India)   25/06/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This prospective observational cohort study aims to assess the predictive value of serum D-dimer and procalcitonin levels at admission in determining the severity of acute pancreatitis (AP). The study will include adult patients (18–70 years) presenting within 24 hours of symptom onset. The Revised Atlanta Classification and Modified Marshall Scoring System will be used to classify AP severity and assess organ dysfunction. Given the associations of AP with systemic inflammation, sepsis, and microvascular thrombosis, procalcitonin and D-dimer levels may serve as early biomarkers for severity assessment. A total of 62 patients will be recruited, accounting for a 10% dropout rate. Blood samples will be collected at admission for D-dimer and procalcitonin measurements. Patients will be monitored for up to 8 days or until discharge for development of complications, organ failure, and outcomes. Data will be analysed using SPSS, with ROC curve analysis to evaluate the predictive accuracy of both biomarkers. Multiple regression will identify independent predictors of severity and mortality. The study seeks to establish whether these biomarkers can aid in early risk stratification and guide clinical decision-making in acute pancreatitis.

 
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