Endometriosis
Conditions
Keywords
Near Infrared Fluorescence Imaging, Indocyanine green (ICG)
Brief summary
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.
Interventions
DEVICENIRF imaging
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.
Sponsors
Maastricht University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective laparoscopic surgery in which endometriosis is suspected * Able to understand the nature of the study and what will be required of them * Females * Age \>18years * Premenopausal * No history of impaired liver and renal function * No history of hypersensitivity or allergy to indocyanine green or iodide * No hyper-thyroidism or autonomic thyroid adenomas * Willing to participate
Exclusion criteria
* Not able to give written informed consent * Males * Aged \< 18 years * Pregnant or breast-feeding women * Known hypersensitivity or allergy to indocyanine green or iodide * Known hyper-thyroidism or autonomic thyroid adenomas * Not willing to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of detected endometriotic lesions with Near Infrared Light versus with white light | during surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histological assessment of taken biopsies: assessment of localization of ICG uptake | biopsies taken during surgery, which are assessed during the 1th week after surgery | 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. |
| Time measurement | during the laparoscopic procedure | measuring the total operating time, and the extra time needed for fluorescence imaging |
| Safety of the procedure: assessment of complications during the procedure attributable to the technique or dye | during surgery | Complications during the diagnostic laparoscopy attributable to the imaging technique or dye are described here. |
| Satisfaction of the surgeon with the technique | immediately after surgery | Immediately the surgeon will be asked whether he/she considered the use of NIRF imaging an useful additive to the procedure. |
| Histological assessment of taken biopsies: assessment Target to background ratio | biopsies taken during surgery, which are assessed during the 1th week after surgery | 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. |
Countries
Netherlands
Outcome results
None listed