| 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
|
|
|
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
|
|
|
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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