Diagnostic Value of ICG in Endometriosis

Early Phase 1CompletedNCT03850158

Insel Gruppe AG, University Hospital Bern63 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Endometriosis Laparoscopy Near Infrared Fluorescence Imaging Indocyanine Green (ICG)

Interventions

Indocyanine GreenDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital

Bern, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 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

Data from ClinicalTrials.gov

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