| CTRI Number |
CTRI/2024/07/071111 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
Clinico Radiological Biochemical Parameters In Predicting The Severity Of Acute Pancreatitis. |
|
Scientific Title of Study
|
A Prospective Study of Clinico Radiological Biochemical Parameters in predicting The Severity 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 |
Bikkumalla Shruthi |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of HIgher Education and Research |
| Address |
Department of General Surgery, AVBRH hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute Of Higher Education And Research, Sawangi(meghe),Wardha,Pincode -442004,Maharashtra.
Wardha
MAHARASHTRA
442004
India |
| Phone |
9618726669 |
| Fax |
|
| Email |
sbikkumalla9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh R Chandak |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of HIgher Education and Research |
| Address |
Department of General Surgery,Jawaharlal Nehru Medical College ,Sawangi(meghe),Wardha,Pincode -442004,Maharashtra.
Wardha
MAHARASHTRA
442004
India |
| Phone |
9422143503 |
| Fax |
|
| Email |
srchandak63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh R Chandak |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of General Surgery, Jawaharlal Nehru Medical College ,Sawangi(meghe),Wardha,Pincode -442004,Maharashtra.
Wardha
MAHARASHTRA
442004
India |
| Phone |
9422143503 |
| Fax |
|
| Email |
srchandak63@gmail.com |
|
|
Source of Monetary or Material Support
|
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH,SAWANGI MEGHE. |
|
|
Primary Sponsor
|
| Name |
Bikkumalla Shruthi |
| Address |
Department of General Surgery,Acharya Vinobha Bhave Rural Hospital,Jawaharlal Nehru Medical College ,dmiher,Sawangi(meghe),Wardha,Pincode -442004,Maharashtra. |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Suresh R Chandak |
Jawaharlal Nehru Medical College,sawangi(meghe) wardha,442004. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bikkumalla Shruthi |
ACHARYA VINOBHA BHAVE RURAL HOSPITAL,WARDHA |
Department of General Surgery,AVBRH Hospital , Jawaharlal Nehru Medical college,sawangi(meghe),wardha,442004
Wardha
MAHARASHTRA |
7569555986
sbikkumalla9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ,Re-red. No: ECR/440/InsUMH/2013/RR-2019 Sawangi(Meghe),Wardha- 442107, Maharashtra,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All Patients of acute pancreatitis OPD and IPD
All patients above 18 years of age
All patients who give consent for the study.
|
|
| ExclusionCriteria |
| Details |
All other causes of acute pancreatitis
Chronic pancreatitis
Patients on immunosuppressive therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Primary Outcome Of This Study is predicting the Severity of Acute Pancreatitis by Clinicoradiological and Biochemical Parameters. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Comparision of sensitivity & specificity |
2 Years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/07/2024 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
Acute pancreatitis is
a condition in which the patient complains of acute attack of abdominal pain
which may occur suddenly or gradually over a period of several hours and
presents with a complex of symptoms
which progress to a severe necrotizing form with organ failure and mortality. Presentation of acute
pancreatitis can vary from mild dull aching pain to frank guarding and rigidity
with associated systemic symptoms.For this, relevant
radiological investigations should be done so that a fast and definitive
diagnosis can be made within a short period of time. Abdominal CECT is considered to be gold standard imaging
for diagnosis,establishing the extent
of disease process
and grading its severity,necrosis, pseudocysts,abscess and prognosis of outcome. Despite of
considering conservative management, the decision to proceed with emergency
laparotomy remains subjective and is strictly based on symptoms, clinical and
laboratory findings and imaging studies. Hence a thorough clinical examination
remains the most important determinant for conserving a case of acute
pancreatitis. Based on the severity of the disease, acute pancreatitis is divided into the following types;
Organ failure and other local or systemic consequences are not present in moderate acute
pancreatitis.
• In cases of moderately severe acute pancreatitis, there may be local problems that last for less
than 48 hours, either with or without organic failure.
• One or more organs may be involved in severe acute pancreatitis, which is characterized by
persistent organ failure lasting longer than 48 hours. The aim of this research is to ascertain how clinical , biochemical and radiological
markers relate to the degree of acute pancreatitis prediction
|