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Endometriosis is a common disease for which the current gold standard for diagnosis is a diagnostic laparoscopy with histologic confirmation. However, during the diagnostic laparoscopy endometriotic lesions are hard to identify due to the many appearances of endometriosis. Our hypothesis is that the use of intra-operative near infrared fluorescence imaging will provide real time image enhancement for the detection of endometriotic lesions by using the different vasculature in the endometriotic lesions. This hypothesis will be tested in a prospective study with 15 patients scheduled for an elective diagnostic laparoscopy for suspected endometriosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIRF imaging | Experimental | After the white light (WL) imaging, NIRF imaging will be performed. 2.5 mg of ICG will be administered i.v. up to 5 times if needed. The lesions identified in WL, are inspected in NIRF mode. The surgeon indicated whether the lesions are more easily identified in WL or the NIRF mode and scores the visibility on a 1-10 scale. Next, inspection will take place for lesions that are seen in NIRF mode but not in WL. Biopsies will be taken from the lesions and from normal tissue for reference and sent for histology. Evaluation will take place whether the lesions differ in histological characteristics |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRF imaging | Device | By using a fluorescence imaging device (with an adapted light source and camera), a fluorescent dye can be made visible. By injecting the fluorescent dye intravenously, the vascularization will be visible. Thereby, structures with altered vascularization are expected to 'light up' differently than the surrounding. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of detected endometriotic lesions with Near Infrared Light versus with white light | The number of lesions detected in near-infrared light will be compared to the number of endometriotic lesions seen in white light. Hereby, we aim to investigate whether all lesions seen in white light are also seen in NIRF light and whether NIRF light shows endometriotic lesions that were not visible in white light. | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Histological assessment of taken biopsies: assessment of localization of ICG uptake | Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another localisation of ICG uptake at cellular level in the different histological subtypes. | biopsies taken during surgery, which are assessed during the 1th week after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurents Stassen, M.D, Ph.D | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6202 | Netherlands |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Time measurement | measuring the total operating time, and the extra time needed for fluorescence imaging | during the laparoscopic procedure |
| Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye | Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here. | during surgery |
| Satisfaction of the surgeon with the technique | Immediately the surgeon will be asked whether he/she considered the use of NIRF imaging an useful additive to the procedure. | immediately after surgery |
| Histological assessment of taken biopsies: assessment Target to background ratio | The biopsies taken during surgery will be analysed together with the video recordings. Hereby, we aim to investigate whether the different histological subtypes of endometriosis light up differently in NIRF light. We interested in whether there is another target to background rato in the different histological subtypes. | biopsies taken during surgery, which are assessed during the 1th week after surgery |
| D000091662 | Genital Diseases |