ICG for Visualization of the Ureters in DIE

NCT05206279 | Unknown

• 1 other identifier: Lavic-Trial
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Endometriosis is a common condition with an incidence of approximately 10% of all women in the fertile phase. Deep infiltrating endometriosis (DIE) has been shown to be associated with high morbidity. A retrospective study of 700 patients has shown lower urinary tract involvement in up to 52.6% of cases with DIE. In most studies, the bladder is cited as the most common site of DIE in the urinary tract, with the ureter being the second most common lesion site. In cases of ureteral endometriosis, a procedure called ureterolysis is essential because complete resection of the endometriosis is necessary to resolve or prevent renal obstruction. In addition, ureterolysis is obligatory in the context of dissection of endometriosis involving the rectovaginal septum, sacrouterine ligaments, or rectum. Ureterolysis is the process of freeing the ureter from both endometriotic nodules as a therapeutic procedure and from physiologic surrounding tissue and structures for complete visualization. Because ureterolysis is a high-risk procedure for ureteral lesions, alternatives are desirable. ICG is a fluorescent dye that has been used for decades for various indications, including retinal angiography, determination of tissue viability, and testing of cardiac and liver function. It has gained an important role in intraoperative visualization of tissue perfusion as well as sentinel lymph nodes in tumor surgery. ICG has also been used and described for ureteral imageability. However, these studies included small populations of 10-30 patients. None of the aforementioned studies have investigated the imageability of the ureters in endometriosis and with regard to a possible reduction in the need for ureteral dissection. The investigators perform a cystoscopy with a retrograde injection of ICG in both ureters. ICG and thus the ureters are visualized during laparoscopy by near-infrared light contained in our camera systems. The additional use of fluorescence imaging of the ureters with ICG injected into the ureters during laparoscopic resection of deep infiltrating endometriosis is intended to improve visualization of the ureters and thus may prevent complete ureterolysis, which is considered a high-risk procedure. It is a safe procedure as ICG has been shown to have an excellent safety profile. The aim of the study is to prove the feasibility of ureteral visualization using intraureteral ICG in 2D laparoscopy for women with deep infiltrating endometriosis by means of near-infrared fluorescence imaging of the ureters. In our secondary endpoints the investigators want to describe the duration time of ICG injection, the duration until visualization of the ureters, the detection rate of fluorescing ureters after ICG-injection, the duration until maximum fluorescence is achieved, the duration until the ureters can no longer be displayed, the length of performed ureterolysis in centimeters and the safety of intraureteral ICG injection.

Conditions

Visualization of Ureters in Gynecological Surgery; Deep Infiltrative Endometriosis; ICG (Indocyanine Green); Near Infrared Imaging; Laparoscopy

Keywords

endometriosis; ICG; ureter

Outcome Measures

Primary Outcomes (1)

• Feasibility of visualization of the ureters by means of ICG / near-infrared-imaging technique

  The feasibility of the visualization (yes/no) of the ureters using near-infrared fluorescence after retrograde application of ICG into the ureters in patients with suspected or proven deep infiltrating endometriosis undergoing laparoscopy.

  The injection will take place during surgery, the time frame concerning feasibility corresponds to the duration of the surgery (1 up to 500 minutes)

Secondary Outcomes (5)

• Duration time of ICG injection

  The time frame corresponds to the whole time of cystoscopy (1 up to 30 minutes)

• Duration until visualization of ureters

  The time frame corresponds to the time from the injection of ICG into the ureters until a laparoscopic visualization of the ICG-stained ureters with near infrared imaging technique (1 up to 500 minutes)

• Detection rate of fluorescing ureters after ICG-injection

  The ureters will be checked for fluorescence immediately after the ICG-injection and then regularly until the end of operation (1 up to 120 minutes)

• Duration until the ureters can no longer be displayed

  The time frame corresponds to the time between visualization of fluorescent ureter until the ureter can no longer be displayed by means of fluorescence in near infrared imaging (1 up to 500 minutes)

• The length and duration of performed ureterolysis in centimeters

  The time frame corresponds to the duration of performed ureterolysis (30 up to 150 Min.)

Study Arms (1)

ureteral ICG injection

EXPERIMENTAL

There is only one arm of the study. All patients will undergo normal laparoscopy. After examining the abdominal structures for presence of endometriosis as well as performing photographic documentation, cystoscopy with intraureteral administration of ICG will be performed, after which intervention the ureters will be examined by laparoscopy. ICG is injected cystoscopy-guided into the ureters (cystoscopy-guided) in a dosage of 5 or 10ml (25mg ICG in 5 or 10ml NaCl) per ureter as a bolus injection.

Drug: Ureteral injection of Indocyanine Green Powder (diluted)

Interventions

Ureteral injection of Indocyanine Green Powder (diluted) DRUG

The intervention we study is the intraureteral injection of ICG during a laparoscopic deep infiltrative endometriosis resection procedure. Cystoscopy with intraureteral administration of ICG will be performed, after which intervention the ureters will be examined by laparoscopy. ICG is injected cystoscopy-guided into the ureters (cystoscopy-guided) in a dosage of 5 or 10ml (25mg ICG in 5 or 10ml NaCl) per ureter as a bolus injection.

Also known as: Cystoscopy

ureteral ICG injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, Switzerland

RECRUITING

Related Publications (5)

• Liapis A, Bakas P, Giannopoulos V, Creatsas G. Ureteral injuries during gynecological surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):391-3; discussion 394. doi: 10.1007/pl00004045.

  PMID: 11795643 BACKGROUND

• Siddighi S, Yune JJ, Hardesty J. Indocyanine green for intraoperative localization of ureter. Am J Obstet Gynecol. 2014 Oct;211(4):436.e1-2. doi: 10.1016/j.ajog.2014.05.017. Epub 2014 May 14.

  PMID: 24835212 BACKGROUND

• Ianieri MM, Della Corte L, Campolo F, Cosentino F, Catena U, Bifulco G, Scambia G. Indocyanine green in the surgical management of endometriosis: A systematic review. Acta Obstet Gynecol Scand. 2021 Feb;100(2):189-199. doi: 10.1111/aogs.13971. Epub 2020 Sep 7.

  PMID: 32895911 BACKGROUND

• Mandovra P, Kalikar V, Patankar RV. Real-Time Visualization of Ureters Using Indocyanine Green During Laparoscopic Surgeries: Can We Make Surgery Safer? Surg Innov. 2019 Aug;26(4):464-468. doi: 10.1177/1553350619827152. Epub 2019 Feb 8.

  PMID: 30734638 BACKGROUND

• Knabben L, Imboden S, Fellmann B, Nirgianakis K, Kuhn A, Mueller MD. Urinary tract endometriosis in patients with deep infiltrating endometriosis: prevalence, symptoms, management, and proposal for a new clinical classification. Fertil Steril. 2015 Jan;103(1):147-52. doi: 10.1016/j.fertnstert.2014.09.028. Epub 2014 Oct 28.

  PMID: 25439849 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Franziska Siegenthaler, PD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cloé J Vaineau, MD

CONTACT

+41797165065; cloe.vaineau@insel.ch

Franziska Siegenthaler, MD

CONTACT

+41797013075

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: January 25, 2022
• Study Start: June 26, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)