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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  
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 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  
Status 
Not Applicable 
 
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.

 
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