Clinical trial NCT03850158: Diagnostic Value of ICG in Endometriosis
Official title: Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Endometriosis
Laparoscopy
Near Infrared Fluorescence Imaging
Indocyanine Green (ICG)
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of detected endometriotic lesions with NIR fluorescence imaging compared to white light laparoscopy
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital
Study officials:
affiliation: Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital, Switzerland
name: Sara Imboden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Siegenthaler F, Knabben L, Mohr S, Nirgianakis K, Imboden S, Mueller MD. Visualization of endometriosis with laparoscopy and near-infrared optics with indocyanine green. Acta Obstet Gynecol Scand. 2020 May;99(5):591-597. doi: 10.1111/aogs.13803. Epub 2020 Jan 28.