| CTRI Number |
CTRI/2016/02/006593 [Registered on: 01/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
02/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effeect of Intra operative Coeliac plexus alcohol neurolysis combined with Frey’s procedure for effective pain relief in patients with Chronic Calcific Pancreatitis |
|
Scientific Title of Study
|
Intra operative Coeliac plexus neurolysis combined with Frey’s procedure for effective pain relief in patients with Chronic Calcific Pancreatitis-
A Prospective randomized double-blind placebo controlled trial |
| Trial Acronym |
INFARCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bala Kumaran |
| Designation |
Postgraduate in MCh SurgicalGastro Enterology |
| Affiliation |
MADRAS MEDICAL COLLEGE |
| Address |
2nd TOWER,4th floor,INSTITUTE OF SURGICAL GASTROENTEROLOGY,RAJIVGANDHI GOVERNMENT GENERAL HOSPITAL ,MADRAS MEDICAL COLLEGE,CHENNAI.600003
Chennai
TAMIL NADU
600003
India |
| Phone |
919486142818 |
| Fax |
|
| Email |
bala.mmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDKannanMCh FRCS |
| Designation |
Director &HOD, SurgicalGastro Enterology |
| Affiliation |
INSTITUTE OF SURGICAL GASTROENTEROLOGY,MADRAS MEDICAL COLLEGE |
| Address |
2nd TOWER,4th floor,,RAJIVGANDHI GOVERNMENT GENERAL HOSPITAL ,MADRAS MEDICAL COLLEGE,CHENNAI.600003
2nd TOWER,4th floor,INSTITUTE OF SURGICAL GASTROENTEROLOGY,RAJIVGANDHI GOVERNMENT GENERAL HOSPITAL ,MADRAS MEDICAL COLLEGE,CHENNAI.600003
Chennai
TAMIL NADU
600003
India |
| Phone |
9841016958 |
| Fax |
|
| Email |
malarkan08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bala Kumaran |
| Designation |
Postgraduate in MCh SurgicalGastro Enterology |
| Affiliation |
MADRAS MEDICAL COLLEGE |
| Address |
2nd TOWER,4th floor,INSTITUTE OF SURGICAL GASTROENTEROLOGY,RAJIVGANDHI GOVERNMENT GENERAL HOSPITAL ,MADRAS MEDICAL COLLEGE,CHENNAI.600003
Chennai
TAMIL NADU
600003
India |
| Phone |
919486142818 |
| Fax |
|
| Email |
bala.mmc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Surgical Gastro Enterology |
| Address |
Tower 2 ,4th floor,
Madras Medical College,
Chennai.600003,Tamilnadu
Tamilnadu |
| 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 |
| Balakumaran Sathyamoorthy |
Madras Medical college |
2ND TOWER,4 th FLOOR, Government Rajiv Gandhi General Hospital
Madras medical college
Chennai-600003
Chennai
TAMIL NADU |
9486142818
bala.mmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Madras Medical College,Chennai -600003 |
Approved |
| Institutional Ethical Committee,Madras Medical College,Chennai -600003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Calcific Pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra operative Celiac plexus Neurolysis either by Absolute alcohol |
The treatment for Chronic pancreatitis is Frey’s procedure in both the Groups.
Along with that for Group 1 Coeliac plexus neurolysis will be done with absolute alcohol 99.6%(Medical Grade),&for Group2;Saline injection will be done as a placebo.
|
| Comparator Agent |
Saline placebo in Group 2 |
The treatment for Chronic pancreatitis is Frey’s procedure in both the Groups. Along with that for Group 1 Coeliac plexus neurolysis will be done with absolute alcohol 99.6%(Medical Grade),&for Group2;Saline injection will be done as a placebo. |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted with Chronic Calcific Pancreatitis to Surgical gastroenterology ward with pain score of more than 7 & those who quite alcohol & smoking for 6 months were included in our study. |
|
| ExclusionCriteria |
| Details |
Patients with mild pain,
those who continue to have alcohol& smoking
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in pain score(Visual analoque scale) QUALITY OF LIFE decrease in the analgesic intake |
6 months 2 years 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Does it have any influence on Post operative insulin intake and improvement in steatorrhoea. |
6 months&2 years,5 years |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Abstract subitted and presented at IHPBA conferrence as short term analysis. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In a randamized trial the efficacy of intaoperative celial plexus neurolysis when combined with Frey’s procedure in the treatment of pain from chronic calcific pancreatitis& improvement in Quality of Life .70 patients with CCP were divided in to 2 groups 35 patients undergo NCPB&Frey’s procedure(GROUP-1)and 35 with only Frey’s procedure (GROUP-2).Immmediate &short term pain relief (Visual analog scale),QOL,mean analgesic consumption ,mortality and morbidity were evaluated at follow up.
|