| CTRI Number |
CTRI/2024/11/077073 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of pain relieving effectiveness of celiac plexus neurolysis against intravenous analgesic during percutaneous biliary surgeries in patients with upper abdominal malignancies |
|
Scientific Title of Study
|
Analgesic efficacy of celiac plexus neurolysis in patients undergoing percutaneous biliary intervention with upper abdominal malignancies |
| 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 Vivek Patre |
| Designation |
Professor |
| Affiliation |
Pt. J.N.M. Medical college Raipur |
| Address |
B-20, Ravinagar, Shyam plaza, Pandri Raipur Raipur CHHATTISGARH 492004 India |
| Phone |
9329399994 |
| Fax |
|
| Email |
drpatrevivek@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ghanshyam Verma |
| Designation |
Post graduation resident |
| Affiliation |
Pt. J.N.M. Medical college Raipur |
| Address |
Purani basti tilda, ward no. 19 Tilda-Neora, Post Neora Raipur CHHATTISGARH 493114 India |
| Phone |
7770848303 |
| Fax |
|
| Email |
ghanshyamverma450@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vivek Patre |
| Designation |
Professor |
| Affiliation |
Pt. J.N.M. Medical college Raipur |
| Address |
B-20, Ravinagar, shyam plaza, pandri Raipur Raipur CHHATTISGARH 492004 India |
| Phone |
9329399994 |
| Fax |
|
| Email |
drpatrevivek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt JNM Medical college Raipur Chhattisgarh
Address- Moudhapara 492001, District Raipur, Chhattisgarh, INDIA |
|
|
Primary Sponsor
|
| Name |
Pt. J.N.M. Medical College Raipur C.G. |
| Address |
Raipur, 492001, jail road, moudahapara |
| Type of Sponsor |
Government medical college |
|
|
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 Ghanshyam Verma |
PT J.N.M. MEDICAL COLLEGE RAIPUR |
Department of radio-diagnosis, Ground floor Pt JNM medical college affiliated Dr. BRAMH hospital Raipur, moudhapara 492001 Raipur CHHATTISGARH |
7770848303
ghanshyamverma450@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITEE PT JNM MEDICAL COLLEGE RAIPUR (C.G.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C221||Intrahepatic bile duct carcinoma, (2) ICD-10 Condition: C170||Malignant neoplasm of duodenum, (3) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (4) ICD-10 Condition: C24||Malignant neoplasm of other and unspecified parts of biliary tract, (5) ICD-10 Condition: C259||Malignant neoplasm of pancreas, unspecified, (6) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Celiac Plexus Neurolysis |
Percutaneous CT guided retrocrural space injection of 10% liquid phenol in celiac ganglion leading to abolishment of pain sensation arising from celiac plexus during percutaneous biliary intervention |
| Comparator Agent |
Intravenous Analgesic |
Analgesic effect of intravenous injection of analgesic (narcotic class) while performing percutaneous biliary intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults with upper abdominal malignancy
2)Should have pain (score in NRS equals or more than 7 out of 10)
3) Should have biliary dilatation and clinical jaundice
|
|
| ExclusionCriteria |
| Details |
Ascites, Hepatic encephalopathy, Patient denial, Active biliary infection |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain intensity in terms of NRS score |
Immediate and 1 day post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complication rate |
Day 0 |
|
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="0" Months="6" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - will be published at journal
- For how long will this data be available start date provided 26-06-2024 and end date provided 26-04-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Malignant
biliary obstruction is an enfeebling condition that can causes pain, jaundice,
pruritus, anorexia, metabolic encephalopathy and later can cause mortality. For
its definitive management biliary decompression is performed via endoscopic,
percutaneous, and surgical approaches. Minimally invasive (Percutaneous)
techniques are now choice of care, preferable to conventional surgical bypass
because of lower intraprocedural morbidity and lower overall hospital stay. Percutaneous biliary drains are often
painful due to measures during PTBD provoke intense pain sensations of very
short duration such as mechanical stretching of biliary tree, peritoneal
transgressions or balloon dilatation procedures and caustic nature of bile
which may inflame the skin near the insertion site, Therefore, another measures
to be taken care about is the optimal pain management of the patients
undergoing percutaneous biliary intervention. Another point of concern
is the development of tolerance to opioid analgesics which is a major
barrier to clinical opioid therapy. Opioid tolerance is a pharmacological
phenomenon caused by repeated opioid exposure leads to receptor resistance that
causes decreased analgesic effects. hence the effective means to ease the
intractable visceral pain associated with abdominal malignancy is to interrupt
the nociceptive impulses at the level of the celiac plexus or splanchnic
nerves. So our aim of the study is
to assess the Analgesic efficacy of celiac plexus neurolysis in patients
undergoing percutaneous biliary intervention with upper abdominal malignancies. Firstly the patient with
upper GI malignancy with pain score equal to or more than 7 with biliary
dilatation will be taken for study with no exclusion criteria should be met. After
pre-operative assessment, proper written consent the patient will be divided
into 2 groups, 1st group will receive Celiac plexus neurolysis for
the management of pain followed by percutaneous biliary intervention while the
2nd group will be directed to percutaneous biliary intervention with
support of intravenous analgesia inter-operatively. Our objective
is to asses the peri-operative and post-operative (1 day) pain with the help of
NRS (numerical response scale) in both groups.
Followed
by comparison of mean NRS score in both groups using required software (SPSS)
and calculate the test of significance. |