| CTRI Number |
CTRI/2025/05/087514 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing a new way to see the windpipe in patients undergoing foodpipe surgery using a special dye mist |
|
Scientific Title of Study
|
Feasibility and safety of indocyanine green nebulization for identification of tracheobronchial tree in patients undergoing minimally invasive esophagectomy - a 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 Aman Bansal |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Surgical Gastroenterology Department, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9478544001 |
| Fax |
|
| Email |
a.bansal0601@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirjhar Raj Rakesh |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Surgical Gastroenterology Department, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8886060312 |
| Fax |
|
| Email |
gis@aiimsrishikesh.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aman Bansal |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Surgical Gastroenterology Department, AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9478544001 |
| Fax |
|
| Email |
a.bansal0601@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Rishikesh, Uttrakhand, India Pin-249203 |
|
|
Primary Sponsor
|
| Name |
Surgical Gastroenterology Department AIIMS Rishikesh |
| Address |
Surgical Gastroenterology Department, AIIMS Rishikesh, Uttrakhand, India Pincode -249203 |
| 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 Aman Bansal |
AIIMS Rishikesh |
Surgical Gastroenterology OPD Level 5 C5L5
Dehradun
UTTARANCHAL |
9478544001
a.bansal0601@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences, Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indocyanine green nebulization |
7.5mg ICG, single dose, nebulisation route over 10 minutes |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the age of 18-80 years
2. Patients willing to participate in the study by giving a written informed consent.
3. ECOG less or equal to 2
4. All patients undergoing MIE for esophageal and esophagogastric junction malignancy or benign pathology
|
|
| ExclusionCriteria |
| Details |
1. Age of patients less than 18 year
2. Allergy to Iodine or ICG
3. Patient not willing to be a part of study
4. Patients unfit for GA
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Florescence Of Tracheo-Bronchial Tree |
Before beginning of esophageal mobilisation and then it will be noted till end of surgery before removing port |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tracheo-bronchial injury identified intra-operatively |
Intra-operatively at any point of time |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
03/06/2025 |
| 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="2"
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
|
Use of ICG fluorescence-guided surgery can assist the surgeon in identifying the trachea-bronchial tree and hence prevent its injury intra-operatively. This may lead to improved post operative outcome and reduced post op stay of patient. Use of ICG in an aerosol form via this nebulisation route has not been described to assess trachea-bronchial tree before and the aim of this study is to assess the feasibility and safety of the same.
|