| CTRI Number |
CTRI/2021/01/030634 [Registered on: 20/01/2021] Trial Registered Prospectively |
| Last Modified On: |
08/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to compare various scoring systems to predict the severity of acute pancreatitis (sudden inflammation of pancreas) caused by gallstones. |
|
Scientific Title of Study
|
Comparison of Ranson, Glasgow, BISAP, JSS and MCTSI scores for predicting the severity of acute gallstone induced pancreatitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mukul Sharma |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Senior Resident, Department of General Surgery, Indira Gandhi Medical College
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018547474 |
| Fax |
|
| Email |
mukulmuki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mukul Sharma |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Senior Resident, Department of General Surgery, Indira Gandhi Medical College
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018547474 |
| Fax |
|
| Email |
mukulmuki@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukul Sharma |
| Designation |
Senior Resident |
| Affiliation |
Indira Gandhi Medical College, Shimla |
| Address |
Senior Resident, Department of General Surgery, Indira Gandhi Medical College
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7018547474 |
| Fax |
|
| Email |
mukulmuki@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College, Shimla, Himachal Pradesh 171001 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College |
| Address |
Indira Gandhi Medical College, Shimla, Himachal Pradesh 171001 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Mukul Sharma |
Indira Gandhi Medical College |
Department of General Surgery, Indira Gandhi Medical College, Shimla, Himachal Pradesh Pin-171001
Shimla
HIMACHAL PRADESH |
7018547474
mukulmuki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IGMC Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K851||Biliary acute pancreatitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients of acute gallstone induced pancreatitis presenting to the emergency department of IGMC Shimla.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant females
2. Patients below 18 years of age
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prediction of severe acute gallstone induced pancreatitis by various scoring systems. |
Baseline, 5 days, 10 days and 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality rate in patients of acute gallstone induced pancreatitis. |
Baseline, 5 days, 10 days and 15 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/01/2021 |
| Date of Study Completion (India) |
31/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/07/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute pancreatitis, which is sudden inflammation of the pancreas, is a common disease requiring hospitalisation. There are various causes of acute pancreatitis, out of which gallstones are the most common cause. Severe acute pancreatitis is not very common (20%) however associated with very high complication and mortality rate compared to mild pancreatitis. If we can predict as to which patients will develop severe pancreatitis, it will help a lot in the management of these patients. Many scoring systems and markers are available for this purpose. In this proposed study various scoring systems (Ranson, Glasgow, BISAP, JSS and MCTSI) will be compared for the prediction of severe acute pancreatitis. All patients of acute gallstone induced pancreatitis presenting to the department of surgery will be included in this study and the above mentioned scores will be calculated for each one of them. These patients will then be observed daily from the day of admission to the day of discharge/death and the severity of acute pancreatitis will be ascertained as per the revised Atlanta classification. This data will be compared to the scoring systems included in this study and the best scoring system to predict severe acute gallstone induced pancreatitis will be determined. This will help a lot in the management of patients with acute gallstone induced pancreatitis in the future. |