| CTRI Number |
CTRI/2024/08/072055 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find out the prognostic indicator of acute pancreatitis. |
|
Scientific Title of Study
|
PROGNOSTIC INDICATORS DETERMINING THE OUTCOME OF 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 |
Dr Harsh Singh Yadav |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of medical science Saifai Etawah |
| Address |
Department of general surgery
Etawah
UTTAR PRADESH
205264
India |
| Phone |
9112556214 |
| Fax |
|
| Email |
doctorharshsinghyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Rajesh Kumar |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Sciences, Saifai Etawah. |
| Address |
Department of general surgery
Etawah
UTTAR PRADESH
205264
India |
| Phone |
9112556214 |
| Fax |
|
| Email |
Verma.rajesh4848@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsh Singh Yadav |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of medical science Saifai Etawah |
| Address |
Department of general surgery
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9112556214 |
| Fax |
|
| Email |
doctorharshsinghyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of general surgery Uttar pradesh university of medical science, saifai , Etawah 206130 Uttar Pradesh , India |
|
|
Primary Sponsor
|
| Name |
Dr Harsh Singh Yadav |
| Address |
Department of general surgery
UPUMS Saifai, Etawah , Uttar Pradesh , India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harsh Singh yadav |
Uttar Pradesh University of medical science saifai Etawah |
Department of general surgery
Etawah
UTTAR PRADESH |
9112556214
doctorharshsinghyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Uttar Pradesh University of medical science, saifai , Etawah |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with acute pancreatitis clinically, biochemical and radiologically. |
|
| ExclusionCriteria |
| Details |
Patient with age less than 18 or more than 80yrs.
Known co-morbidities other than diabetes and hypertension.
Pregnant women.
Any malignancy.
H/o tuberculosis
H/o COVID-19
Recurrent pancreatitis
Chronic Pancreatitis
Any upper abdominal surgery.
Patient not willing to follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the correlation of serum amylase lipase with BISAP and APACHE 2 in the patients of acute pancreatitis |
2 weeks and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the better prognosis predictor in patients of acute pancreatitis |
2 weeks & 6 week |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/08/2024 |
| 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 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 study will classify patients according to Atlanta classification then will calculate the BISAP and APACHE 2 of enrolled patients with serum amylase, lipase, CRP , LDH and correlation of biochemical markers with scoring system is done. |