| CTRI Number |
CTRI/2024/07/069750 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparision between intravenous injection and direct gall bladder injection of dye during gall bladder surgery for better picture of structures and reducing surgery time. |
|
Scientific Title of Study
|
Observational study of using indocyanine green via intracholecystic vs intravenous route during laparoscopic cholecystectomy to analyse intraoperative biliary anatomy and reduction in time of surgery. |
| 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 Damini Nagpal |
| Designation |
Junior Resident |
| Affiliation |
KLE University Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery KLE Jawaharlal Nehru Medical
College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
09357922272 |
| Fax |
|
| Email |
drdamininapgal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Togale |
| Designation |
Professor |
| Affiliation |
KLE University Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery KLE Jawaharlal Nehru Medical
College Belgaum
College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
09844706266 |
| Fax |
|
| Email |
zapmanojtogale@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Togale |
| Designation |
Professor |
| Affiliation |
KLE University Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery, KLE Jawaharlal Nehru Medical
College Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
09844706266 |
| Fax |
|
| Email |
zapmanojtogale@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, KLE Jawaharlal Nehru Medical
College, Belgaum
Karnataka 590010, India |
|
|
Primary Sponsor
|
| Name |
Dr Damini Nagpal |
| Address |
Department Of General Surgery, KLE Jawaharlal Nehru Medical
College Belgaum, Karnataka 590010, India |
| Type of Sponsor |
Other [self] |
|
|
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 Damini Nagpal |
KLE’s Dr. Prabhakar Kore Hospital and Medical Research Centre |
Department Of General Surgery, KLE Jawaharlal Nehru Medical
College Belgaum, Karnataka 590010
Belgaum
KARNATAKA |
09357922272
drdamininapgal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients falling in above mentioned age group and those willing to give consent for the same. |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to indocyanine green dye.
Densely adherent or intrahepatic gall bladder.
Pregnant and breastfeeding females.
Patients with carcinoma gall bladder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the two methods for better delineation of biliary anatomy |
Intraoperative during time of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to know the time difference in visualization of cystic duct & total time taken for completion of surgery between the two methods. |
intraoperative during the time of surgery |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
15/07/2024 |
| 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) |
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
|
Cholecystectomy is one of the most commonly performed procedures on a global scale. It is the gold standard for benign gall bladder surgery but is associated with non-negligible incidence of bile duct injuries due to misinterpretation of biliary anatomy. several techniques have been proposed for the better identification of biliary anatomy, one of them being use of indocyanine green. This study evaluates the efficacy of indocyanine green dye by intacholecystic and intravenous route during laparoscopic cholecystectomy in visualization of biliary anatomy in order to reduce possible injuries, time of surgery and related complications. |