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CTRI Number  CTRI/2024/04/065580 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Triglyceride Levels and Acute Pancreatitis- A Correlation 
Scientific Title of Study   Correlation between Triglyceride Levels and Acute Pancreatitis 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vasundara Gopalan 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  General Surgery Department,Jawaharlal Nehru Medical College,Sawangi, Wardha, Pincode-442004

Wardha
MAHARASHTRA
442004
India 
Phone  8095908030  
Fax    
Email  piggy.aruna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Darshana Tote 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  General Surgery Department,Jawaharlal Nehru Medical College,Sawangi, Wardha, Pincode-442004

Wardha
MAHARASHTRA
442004
India 
Phone  9923129974  
Fax    
Email  drtotedarshana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Darshana Tote 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  General Surgery Department,Jawaharlal Nehru Medical College,Sawangi, Wardha, Pincode-442004

Wardha
MAHARASHTRA
442004
India 
Phone  9923129974  
Fax    
Email  drtotedarshana@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha 
 
Primary Sponsor  
Name  Vasundara Gopalan 
Address  Room No- T 12, Shalinitai Hostel, Sawangi, Wardha, Maharashtra, Pincode 442004 
Type of Sponsor  Other [Self] 
 
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 Vasundara Gopalan  Acharya Vinoba Bhave Rural Hospital  General Surgery Department,Jawaharlal Nehru Medical College,Sawangi, Wardha, Pincode-442004
Wardha
MAHARASHTRA 		 8095908030

piggy.aruna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, D.M.I.M.S.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients diagnosed with Acute Pancreatitis on the basis of clinical examination, laboratory and radiological investigations.

Age more than 18 and less than 70 years.

All patients consenting for study. 
 
ExclusionCriteria 
Details  Pregnanat women.
K/C/O Diabetes Mellitus, Hypertension, CKD, Cardio Vascular disease.
K/C/O Hyper Triglyceridemia syndrome.
Coexisting major disease with Acute Pancreatitis such as upper GI bleed that requires invasive endoscopic/ radiological/ surgical procedure or that involves duodenal perforation or perforation of bile duct.
Patients who come to hospital 72 hours after the onset of symptoms
Patinets with other pathology not relating to Acute Pancreatitis.
Patients fasting for more than 48 hours or use of parenteral nutrition. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To check the use of triglyceride levels to assess severity of acute pancreatitis  Triglyceride levels and other investigations will be done at the time of admission/ zero hour 
 
Secondary Outcome  
Outcome  TimePoints 
Through this study, we aim to assess various etiologies of acute pancreatitis, pattern of triglycerides in acute pancreatitis & to assess the pattern of severity of acute pancreatitis.  3 DAYS  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   23/04/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 01-03-2024 and end date provided 01-03-2029?
    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 - NIL
Brief Summary   After obtaining the written informed consent from study participants to participate in the study and for publication of their data, patients who are diagnosed with acute pancreatitis on the basis of clinical examination, laboratory and radiological investigation will be considered for the study. Severity of acute pancreatitis will be assessed based on Modified Atlanta Scoring system and the same will be co related with triglyceride levels. Statistical analysis will be done and results will be published. 
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