Diagnostic Value of ICG in Endometriosis

Study Overview
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Brief Summary
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This study evaluates the diagnostic value of the addition of indocyanine green and near infrared fluorescence imaging during laparoscopy in patients with suspected endometriosis.

Detailed Description
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Endometriosis is a public health problem with an increasing incidence and various symptoms. Surgical treatment reliefs pain and improves fertility by radically removing endometriotic lesions. However, peritoneal endometriotic lesions may vary significantly in their appearance in standard white light laparoscopy and therefore may be difficult to be identified. Because endometriosis is associated with hypervascularisation the visualization of tissue perfusion by additional use of near infrared (NIR) fluorescence imaging with indocyanine green (ICG) may improve the detection of peritoneal endometriotic lesions.

Official Title
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Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green

Conditions
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Endometriosis, Laparoscopy, Near Infrared Fluorescence Imaging, Indocyanine Green (ICG)

Intervention / Treatment
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* Drug: Indocyanine Green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent as documented by signature Be premenopausal (menopause is defined as amenorrhea lasting one year or longer) Patients should be in follicular phase Have chronic pelvic pain and/or Infertility and be willing to undergo planned endometriosis resection procedure. Exclusion Criteria: Known or suspected allergy to iodine, shellfish, or ICG dye Hyperthyroidism Severe renal insufficiency Simultaneous therapy with beta-blockers Women who are pregnant (positive HCG in the blood) or breast feeding Intention to become pregnant during the course of the study Inability to follow the procedures of the study (due to language problems, psychological disorders, dementia) Active pelvic infection (positive vaginal or cervical smears for bacteria or elevated markers of infection in the blood) Previous history of radiation therapy of the pelvis Presence of medical conditions contraindicating general anesthesia or standard laparoscopic surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm, ICG and NIR imaging<br>NIR fluorescence imaging is performed after white light laparoscopy. 0.3mg/kg bodyweight of ICG is administered i.v. All suspected lesions are removed and labeled whether they are seen in WL or NIR imaging or both. Evaluation is performed after the histological analysis of the lesions. | Drug: Indocyanine Green<br>* Indocyanine green is administered intra-venous after dilution with water in a peripheral vein at a dosage of 0.3mg/kg body weight as a bolus injection. The injection will take place during surgery. By using NIR fluorescence imaging ICG is made visible.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of detected endometriotic lesions with NIR fluorescence imaging compared to white light laparoscopy | The number of histologically proven endometriotic lesions detected with NIR fluorescence imaging are compared to the number of lesions detected with white light laparoscopy alone and white light laparoscopy plus NIR fluorescence imaging. | The duration of the participation is from the signature of the informed consent until the end of the hospitalisation, expected to be on average after 2 to 4 days |