| 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 |
|
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Source of Monetary or Material Support
|
|
|
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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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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
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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" |
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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 |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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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