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CTRI Number  CTRI/2024/06/069056 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 22/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Role of NIR in diagnosing endometriosis 
Scientific Title of Study   Near Infra-red Imaging with Indocyanine Green for diagnosis and laparoscopic treatment of Endometriosis 
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 Shazia Khan 
Designation  Associate Professor 
Affiliation  INHS ASVINI 
Address  Dept of Obs and Gyn , INHS Asvini ,RC Church Road , Colaba Mumbai
I
Mumbai
MAHARASHTRA
400005
India 
Phone  9049484689  
Fax    
Email  drshaziakhan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shazia Khan 
Designation  Associate Professor 
Affiliation  INHS ASVINI 
Address  Dept of Obs and Gyn , INHS Asvini ,RC Church Road , Colaba Mumbai
I
Mumbai
MAHARASHTRA
400005
India 
Phone  9049484689  
Fax    
Email  drshaziakhan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shazia Khan 
Designation  Associate Professor 
Affiliation  INHS ASVINI 
Address  Dept of Obs and Gyn , INHS Asvini ,RC Church Road , Colaba Mumbai

Mumbai
MAHARASHTRA
400005
India 
Phone  9049484689  
Fax    
Email  drshaziakhan@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical Research Committee 
 
Primary Sponsor  
Name  Armed Forces Medical Research Committee 
Address  Office of DGAFMS, A BLOCK 5F, MoD Office Complexes, Africa Avenue, New Delhi 110023 
Type of Sponsor  Government funding agency 
 
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 Shazia Khan  Indian Naval Hospital Ship ASVINI  Dept of Obs and Gyn, INHS Asvini, R C Church Road, Colaba, Mumbai 400005
Mumbai
MAHARASHTRA 
9049484689

drshaziakhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INHS Asvini Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Indocyanine Dye   Drug- Indocyanine green Dye Route - intravenously Dose - 0.25mg/kg Near infra red imaging will be activated on camera after 5mins of injection. Doses will be repeated maximum of three times at a gap of 30 mins. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women 18-45 yrs of age with suspected endometriosis with surgical indication for treatment needing laparoscopic and pathologic confirmation. Patients will be triaged to surgery according to the common indications for endometriosis.  
 
ExclusionCriteria 
Details  A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG; pregnancy or breastfeeding period; the presence of medical conditions contraindicating general anesthesia or standard surgical approaches; and any contraindicating medical condition that make the subject a poor candidate for the investigational procedure. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify and enumerate endometriotic lesions by Indocyanine green dye which were missed by white light laparoscopy and excise them intraoperatively.   At the end of each surgery and assess disease recurrance at 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Disease recurrance  6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="54" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/06/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Indocyanine green (ICG) is nowadays increasingly used in gynecological surgery, both in oncological and benign fields. It is frequently used in the identification of lymphatic tissue, but if injected intravenously, it binds to plasma proteins and persists in the vascular system, helping in the definition of the vascular network 

Given the typical neovascularization of endometriosis, related to chronic inflammation, the visualization of abnormal areas of peritoneal vascularization could be useful to better identify and define the endometriosis lesions in their real extension and to visualize the lesions even when not obvious, as in puckered peritoneal lesions. For all of this, several methods have been proposed to improve the intraoperative treatment of endometriosis through enhancing the human vision power, with encouraging results.

The use of cameras with near-infrared radiation imaging (NIR) after injection of ICG represents one of the most encouraging methods in this experimental scenario, demonstrating a good profile of safety and accuracy as an intraoperative diagnostic method.

The aim of this study is to assess the diagnostic value of NIRICG imaging in the surgical treatment of endometriosis compared with the standard of treatment, that is laparoscopy in white light (WL), and the standard diagnostic method, that is pathologic finding.

A total of 50 women undergoing laparoscopy for suspected endometriosis will be studied over a period of 2 years. It will be a single arm prospective study.

Laparoscopy will be performed using the standard technique of the primary surgeon. During surgery, the abdomen and pelvis will be visually inspected using direct laparoscope visualization under WL conditions. All suspected areas will be classified as either peritoneal superficial endometriosis (PE) or deep infiltrating endometriosis (DIE). All suspected PE will be classified as white, black, and red lesions and documented with their anatomic location in the surgical record under WL condition. Similarly, all suspected DIE lesions will be also recorded with their anatomic location in the surgical record (retrocervical, vaginal, rectosigmoid, bladder lesions, etc.) under WL condition.The patient will then be administered 0.25 mg/kg of ICG intravenously. After an interval time of a minimum of 5 min, NIR-ICG imaging will be activated and the whole surgical field will be inspected with this filter. Doses will be repeated maximum thrice during surgery.

Every specimen resected during surgery will be considered as “suspect lesion” for endometriosis when visualized with WL and/or with NIR-ICG until pathological confirmation is obtained. If a suspect lesion is visualized with NIR-ICG and not in WL or, conversely, only with WL, it will be named “suspect occult lesion” (s-OcL), and only after conformation by pathology, it will be considered “confirmed occult lesion” (c-OcL). In addition, a random control biopsy from an apparent negative peritoneum visualized in WL and NIR-ICG imaging will be taken for all patients (control cases).A surgical specimen will be considered as “pathologic” when containing endometriosis foci (stroma and/or gland and/or hemosiderin) and/or acute or chronic sclerosing inflammatory infiltrate.Perioperative surgical complications will be documented. Statistical calculations will be performed using the Statistical Package for Social Sciences.


 
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