ICG for Visualization of the Ureters in DIE

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jan 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to see the ureters (the tubes that carry urine from the kidneys to the bladder) during surgery for women with deep infiltrating endometriosis (DIE). Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside of it, which can cause pain and other health issues. In this study, researchers will use a special dye called Indocyanine Green (ICG) that makes the ureters visible during laparoscopic surgery. The goal is to improve the visualization of the ureters to potentially reduce the need for a risky procedure called ureterolysis, where the ureters must be freed from endometriosis lesions.

Women who are interested in participating must be at least 18 years old and diagnosed with deep infiltrating endometriosis. They should not have any known allergies to the dye or other specific medical conditions that might complicate the surgery. Participants can expect to receive a safe injection of the dye, which will help doctors see their ureters more clearly during the procedure. Overall, this trial aims to determine if using ICG can make surgeries safer and more effective for women dealing with this challenging condition.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Informed Consent as documented by signature
• • Age 18 or older
• • Premenopausal status (menopause is defined as amenorrhea lasting one year or longer)
• • Proven (by laparoscopy or MRI) or highly suspected (ultrasound or clinically) deep infiltrating endometriosis
• Exclusion Criteria:
• • No DIE detectable intraoperatively
• • Known or suspected allergy to iodine, shellfish, or ICG dye
• • Hyperthyroid metabolic state (excluding treated hyperthyroidism with euthyroid metabolic state)
• • Severe renal insufficiency (GFR \< 30ml/min)
• • Simultaneous therapy with beta-blockers
• • Pregnant (positive human chorionic gonadotropin in the blood) or breastfeeding women
• • 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)
• • Previous history of radiation therapy of the pelvis
• • Presence of medical conditions contraindicating general anesthesia or standard laparoscopic surgery
• • Active, non treated urinary tract infection
• • Active pyelonephritis
• • Women having undergone surgery for reimplantation of the ureters (UCNS) or nephrostomy