| CTRI Number |
CTRI/2019/11/022109 [Registered on: 22/11/2019] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Intraoperative Fluorescence Angiography using Indo Cyanine Green (ICG) during Colorectal Cancer Surgery |
|
Scientific Title of Study
|
Role of Intraoperative Fluorescence Angiography to Prevent Anastomotic Leaks in patients undergoing Anterior resection - a Prospective Randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subramanyeshwar Rao Thammineedi |
| Designation |
Chief Surgical Oncologist and Medical Director |
| Affiliation |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Department of Surgical Oncology,
Basavatarakam Indo American Cancer Hospital and Research Institute,
Road Number 10, Banjara Hills
Hyderabad TELANGANA 500034 India |
| Phone |
9848038716 |
| Fax |
|
| Email |
subramanyesh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajesh Raj Saksena |
| Designation |
Consultant Surgical Oncologist |
| Affiliation |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Department of Surgical Oncology,
Basavatarakam Indo American Cancer Hospital and Research Institute,
Road Number 10, Banjara Hills
Hyderabad TELANGANA 500034 India |
| Phone |
9849167440 |
| Fax |
|
| Email |
drajeshraj@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajesh Raj Saksena |
| Designation |
Consultant Surgical Oncologist |
| Affiliation |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Department of Surgical Oncology,
Basavatarakam Indo American Cancer Hospital and Research Institute,
Road Number 10, Banjara Hills
Hyderabad TELANGANA 500034 India |
| Phone |
9849167440 |
| Fax |
|
| Email |
drajeshraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of surgical oncology, 4th floor, Block no 1, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.
Hyderabad
TELANGANA 500034
India |
|
|
Primary Sponsor
|
| Name |
Basavatarakam Indo American Cancer Hospital and Research Institute |
| Address |
Department of Surgical Oncology,
Basavatarakam Indo American Cancer Hospital and Research Institute
Road number 10, Banjara Hills,
Hyderabad, Telangana 500034 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ajesh Raj |
Basavatarakam Indoamerican cancer hospital and research institute |
Department of surgical oncology, 4th floor, Block no 1, Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad, India.
Hyderabad
TELANGANA 500034
India Hyderabad TELANGANA |
9849167440
drajeshraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Basavatarakam Indo American Cancer Hospital and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ICG Arm |
Assessment of colorectal vascularity after a bolus ICG injection intravenously at the time of surgery. |
| Comparator Agent |
Non ICG arm |
Conventional assessment of colorectal vascularity without ICG assessment under white light |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Medically fit to undergo surgery
2. Who have given informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients not undergoing a colo-rectal/anal anastomosis
2. Patients undergoing synchronous colonic resections
3. Locally advanced rectal cancer requiring extended or multi-visceral resections
4. Coexistent colorectal pathology
5. Previous pelvic RT, recurrent rectal cancers
6. Hepatic dysfunction, renal dysfunction, known allergy to ICG or iodine dyes
7. Pregnancy
8. Did not consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anastomotic leak at 30 days from the day of surgery.
Revision of bowel segment, stoma placement, vascular anomalies - will be recorded intraoperatively |
Anastomotic leak at 30 days from the day of surgery.
Revision of bowel segment, stoma placement, vascular anomalies - will be recorded intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in planned anastomosis |
Intraoperatively |
| Rates of stoma formation |
Intraoperatively |
| Intraoperative and perioperative complications |
30 days from day of surgery |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
02/12/2019 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim:The purpose of the study is to evaluate the role of intraoperative fluorescence angiography using Indocyanine green (ICG) assessment for microperfusion assessment in preventing anastomotic leaks during rectal cancer surgery. The fluorescence assessment is done using a near IR camera system which detects ICG fluorescence using fluorescence detection systems.
Procedure: Following an informed consent, patients with rectal cancer planned for an anterior resection (high or low) will be prospectively randomised in a 1:1 fashion at the time of consenting into a conventional surgery arm (No IFA used) and an IFA arm. Conventional surgery arm (no IFA) Laparoscopic or robot-assisted AR (high or low) will be performed as per the surgeon preference. Perfusion assessment will be performed with white light (WL) only. IFA arm For participants randomized to surgery with IFA, AR will be performed according to the surgeon’s usual technique, using either a laparoscopic or a robotic approach. Two IFA assessments will be performed, each involving an intravenous bolus of 0.1 mg/kg of ICG. The first assessment will be performed after rectal mobilization but before bowel transection. Under white light laparoscopy, the point of planned bowel transection will be first marked. Using either an intra- or extracorporeal IFA technique, the time to first fluorescence and any change in the planned bowel transection point following IFA will be recorded. The second assessment will be performed after construction of the anastomosis. One additional IFA assessment is permitted at the operating surgeon’s discretion. |