Using Indocyanine Green for Better Visualization of Ureters in Endometriosis Surgery
Laparoscopic Visualization of the Ureters Using Near-infrared Fluorescence After Retrograde Application of Indocyanine Green (ICG) in Deep Infiltrating Endometriosis.
This study is testing if a special dye can help doctors see the ureters more clearly during surgery for women with deep endometriosis to reduce the chance of injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bern) |
| Trial ID | NCT05206279 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Indocyanine Green (ICG) for enhancing the visualization of ureters during laparoscopic surgery for deep infiltrating endometriosis (DIE). The study aims to improve surgical outcomes by reducing the risk of ureteral injuries, which are common complications in these procedures. Participants will receive ureteral injections of ICG to facilitate better identification of ureters during surgery. The trial includes premenopausal women diagnosed with DIE, who will be monitored for safety and efficacy of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are premenopausal women aged 18 or older with proven or highly suspected deep infiltrating endometriosis.
Not a fit: Patients who do not have detectable deep infiltrating endometriosis or have contraindications to the use of ICG will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce surgical complications and improve outcomes for women undergoing surgery for endometriosis.
How similar studies have performed: While the use of ICG in surgical procedures is gaining traction, this specific application for ureter visualization in endometriosis surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bern
- Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Franziska Siegenthaler, PD — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Cloé J Vaineau, MD
- Email: cloe.vaineau@insel.ch
- Phone: +41797165065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.