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CTRI Number  CTRI/2026/01/100246 [Registered on: 02/01/2026] Trial Registered Prospectively
Last Modified On: 02/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Study on patients of chronic pancreatitis who require surgery with a novel method additional to routine surgery, involving surgical removal of nerves carrying pain sensation from Pancreas, to see whether the procedure can be done with improvement in pain relief and quality of life of the patients. 
Scientific Title of Study   Assessing the Feasibility and Acceptability of Additional Pancreatic Nerve Plexus Neurotomy for Pain Management in patients undergoing Surgery for Chronic Pancreatitis- A Non-Randomized Interventional (PILOT) Study 
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 SOMNATH MUKHERJEE 
Designation  JUNIOR RESIDENT, DEPARTMENT OF SURGERY 
Affiliation  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY 
Address  Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanvantari Nagar, Puducherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  7427987954  
Fax    
Email  imsomnath4219@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR DEBASIS NAIK 
Designation  ASSOCIATE PROFESSOR, DEPARTMENT OF SURGERY 
Affiliation  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY 
Address  Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanvantari Nagar, Puducherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  8763124660  
Fax    
Email  debasismbbs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SOMNATH MUKHERJEE 
Designation  JUNIOR RESIDENT, DEPARTMENT OF SURGERY 
Affiliation  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY 
Address  Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanvantari Nagar, Puducherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  7427987954  
Fax    
Email  imsomnath4219@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR SOMNATH MUKHERJEE 
Address  Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanvantari Nagar, Puducherry 605006 
Type of Sponsor  Other [SELF] 
 
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 SOMNATH MUKHERJEE  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH  Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education & Research, Dhanvantari Nagar, Puducherry 605006
Pondicherry
PONDICHERRY 
7427987954

imsomnath4219@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-INTERVENTIONAL STUDIES JIPMER,PUDUCHERRY  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  ADDITIONAL THERAPEUTIC PANCREATIC NERVE PLEXUS NEUROTOMY  SURGICAL DIVISION OF PANCREATIC NERVE HEAD PLEXUS ADDITIONAL TO ROUTINE STANDARD SURGICAL PROCEDURE FOR CHRONIC PANCREATITIS- Procedure details for Therapeutic Nerve Plexus Neurotomy: Section of the First Portion- The uncinate process identified by elevating the duodenum and the head of pancreas; freed as well as is possible, from the posterior abdominal wall, with gauze. Extensive Kocherisation done to liberate the head of pancreas; Plexus Pancreaticus Capitalis-I visualised. SMA identified by its pulsation. Large fan-shaped bundle of nerve fibers visualized extending from the right celiac ganglion to the upper medial margin of the uncinate process. Forceps applied, bundle divided. Section of the Second Portion- Plexus Pancreaticus Capitalis-II visualized after careful division of the first portion. Board-like bundle of nerve fibers from the SMA extending over the entire length of medial margin of Uncinate process. Carefully divided, little by little, between clamps, because it usually contains some arterial branches.  
Comparator Agent  ROUTINE STANDARD SURGICAL PROCEDURE FOR CHRONIC PANCREATITIS  RESECTION & DRAINAGE PROCEDURE INVOLVING PANCREATIC HEAD CORING WITH LATERAL PANCREATICOJEJUNOSTONY 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Inclusion Criteria-
Patients undergoing Surgical Procedure for Chronic Pancreatitis and satisfying the following criteria-
ADULT age-group i.e., 18-65 years.
Duration of illness more than 2 years.
IZBICKI Pain Score more than 50.
 
 
ExclusionCriteria 
Details  Exclusion Criteria-
• Individuals with Pseudocyst, Walled-Off Necrosis, Recent attack of Acute Pancreatitis (4 weeks), Obstructive Jaundice, Pancreatic Mass/Lesion (suspected malignancy)
• Patient with Psychiatric Illness
• Patients denying consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the feasibility of Therapeutic Pancreatic Nerve Plexus Neurotomy in addition to Surgery in patients with Chronic Pancreatitis  Baseline (at time of intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effects of Therapeutic Pancreatic Nerve Plexus Neurotomy in addition to Surgery on reduction in Izbicki Pain Score & the Quality-of-Life in patients with Chronic Pancreatitis.

To assess the complications related to the additional Therapeutic Pancreatic Nerve Plexus Neurotomy in further course 
3 months, 6 months 
 
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   Phase 2 
Date of First Enrollment (India)   01/02/2026 
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 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  

In patients known to have chronic pancreatitis, relapsing upper abdominal pain is the main reason to seek surgical treatment. The purpose of surgical therapy is to relieve symptoms, especially pain, and to improve the patient’s quality of life. Several medical, endoscopic and surgical treatment strategies have been employed in routine practice for the purpose of treatment of the disease.
Although surgical approach to chronic pancreatitis has been quite successful, management of patients with intractable pain from chronic pancreatitis has been difficult, often resulting in narcotic addiction and/or malnutrition from major pancreatic resections. In regard to this, a novel approach of Therapeutic Surgical Neurotomy in addition to Routine Standard surgery can be considered beneficial.
Simple denervation of the pancreatic head nerve plexus fibers offers a logical approach of pain relief in chronic pancreatitis. In view of the same, no studies have been conducted on chronic pancreatitis assessing the feasibility of Therapeutic Neurotomy of Pancreatic Nerve Plexus as an adjunct to Standard Surgical Procedures in patients with Chronic Pancreatitis. This novel study thus aims to provide greater insights into the combined approach on Pain Relief, which being the most significant debilitating factor for patients with Chronic Pancreatitis.


 
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