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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 

 
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