| CTRI Number |
CTRI/2024/11/076237 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring How Nerve Activity Affects Pain in Patients with Chronic Pancreatitis: A Study on Understanding Pain Mechanisms |
|
Scientific Title of Study
|
Evaluation of pain patterns in idiopathic chronic pancreatitis patients in the background of central sensitization |
| 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 Rajiv Mehta |
| Designation |
Director & Consultant Gastroenterologist |
| Affiliation |
SIDS hospital and research centre |
| Address |
SIDS healthcare private limited Majura-Khatodara Bamroli road Khatodara
Near Shell petrol pump Majuragate
Surat
Surat GUJARAT 395002 India |
| Phone |
9909907475 |
| Fax |
|
| Email |
rmgastro@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Samir Vanani |
| Designation |
General Medical Practioner |
| Affiliation |
SIDS hospital and research centre |
| Address |
SIDS healthcare private limited
Majura-Khatodara Bamroli road Khatodara
Near Shell petrol pump Majuragate
Surat
Surat GUJARAT 395002 India |
| Phone |
09662179254 |
| Fax |
|
| Email |
samir.vanani@outlook.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mipasha Patel |
| Designation |
General Medical Practioner |
| Affiliation |
SIDS hospital and research centre |
| Address |
SIDS healthcare private limited
Majura-Khatodara, Bamroli road Khatodara
Near Shell petrol pump Majuragate
Surat
Surat GUJARAT 395002 India |
| Phone |
9998213106 |
| Fax |
|
| Email |
mipasha03@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIDS Hospital and Research Centre, Surat, Gujarat, India - 395002 |
|
|
Primary Sponsor
|
| Name |
SIDS Hospital and Research Center |
| Address |
SIDS healthcare private limited
Majura Khatodara
Bamroli Road
Near Shell petrol pump
Majuratgate
Surat
395002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Samir Vanani |
SIDS hospital and research centre |
Room no 503, 5th floor, division of GI research, SIDS healthcare private limited
Majura Khatodara
Bamroli road
Near Shell petrol pump
Majuragate
Surat
395002 Surat GUJARAT |
9662179254
samir.vanani@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SIDS Hospital and Research Centre EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K861||Other chronic pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL as it is an observational study |
NIL as it is an observational study |
| Comparator Agent |
NIL as it is an observational study |
NIL as it is an observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients age within 18 – 65 years.
2) Patients with confirmed diagnosis of definite idiopathic chronic pancreatitis according to the M-ANNHEIM criteria with or without abdominal pain.
3) Patients with moderate or marked ductal lesions based on Cambridge classification using Computerized Tomography (CT) scan or Endoscopic Retrograde Cholangiopancreatography (ERCP) |
|
| ExclusionCriteria |
| Details |
1) Patients suffering from acute pancreatitis at the time of enrolment.
2) Patients suffering from other painful conditions which render them unable to differentiate between pain of chronic pancreatitis and other painful conditions.
3) Patients who are pregnant at the time of enrolment.
4) Patients with the history of alcohol abuse, current alcohol use, illicit substance use, tobacco use, or current smoker.
5) Patients who received surgical intervention for chronic pancreatitis.
6) Pseudocyst size more than 5 cm.
7) Narcotic drug dependence. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate relation of pain patterns (using COMPAT-SF questionnaire) in chronic pancreatitis with central pain sensitization using P-QST method |
Outcome will be measured at the baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate relation of pain patterns with EEG changes to evaluate central pain sensitization. |
Outcome will be measured at the baseline |
| To evaluate relation of pain patterns with inflammatory biomarkers |
Outcome will be measured at the baseline |
|
|
Target Sample Size
|
Total Sample Size="114" Sample Size from India="114"
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)
|
25/11/2024 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pain in chronic pancreatitis (CP) is most common and difficult aspects to manage. About 90% of patients with CP suffer from abdominal pain which remains primary cause of hospitalization. Pain in CP results from complex interplay of morphological (increased parenchymal pressure, pancreatic duct hypertension, pancreatic complications) and neural mechanisms (peripheral and central sensitization). Neuroplasticity is an emerging theory to understand mechanism of pain in CP characterized by peripheral and central pain sensitization, and brain reorganization. It manifests clinically as allodynia and hyperalgesia and perceived as one of the driving reasons of pain in CP. Currently available conventional medical and surgical treatments majorly target morphological aspect of pain mechanism which leads to inadequate pain management. Further research in neuroplasticity and identifying brain regions involved pain sensitization can help in understanding and managing pain in CP in a comprehensive fashion. In this study, we will investigate association between clinical pain patterns with central sensitization and brain reorganization using Pancreatic-Quantitative Sensory Testing (P-QST), functional MRI (fMRI), EEG and serum biomarkers. |