Intraoperative Assessment of Ureteral Perfusion in Women With Endometriosis

Intraoperative Assessment of Ureteral Perfusion Using Indocyanine Green Angiography in Women Submitted to Laparoscopic Surgery for Endometriosis

Deep infiltrating endometriosis (DIE) is a severe form of endometriosis in which lesions affect retroperitoneal tissue and pelvic organs wall. It is often characterized by pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically impacting on women' quality of life. It is typically multifocal, involving uterosacral ligaments, the upper third of posterior vaginal wall, bowel, bladder, and ureters.

Indocyanine green (ICG) is an anionic tricarbocyanine molecule able to bind to plasma proteins into the vascular system and to become fluorescent if excited by near-infrared light (NIR). NIR-ICG imaging is used in gynecology for the intraoperative diagnosis of occult peritoneal and deep endometriosis at white light and to assess tissue perfusion and guide surgical strategy.

Study Overview

• Status: Terminated
• Conditions: Endometriosis
• Intervention / Treatment: Other: Indocyanine green angiography

Detailed Description

Patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of deep endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study.

Ureter perfusion will be intraoperatively assessed using indocyanine green angiography.

After surgery, patients will be included in the post-operative follow-up, as usual in our clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Diego Raimondo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• patients undergoing laparoscopic surgery for endometriosis
• informed consent to participate in the study

Exclusion Criteria:

• known or suspected allergy to iodide
• history of active pelvic infection
• presence of intra-abdominal or pelvic malignancy
• pelvic radiation therapy
• hyperthyroidism
• liver dysfunction
• serum creatinine > 2.0 mg/dL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Women with endometriosis; Women undergoing laparoscopic surgery for endometriosis

Other: Indocyanine green angiography; Intravenous ICG (PULSION Medical Systems SE, Feldkirchen, Germany) will be used for the intraoperative evaluation of ureteral vascularization. Twenty-five milligrams of indocyanine green will be diluted in 10 ml of soluble water, and a bolus of 0.25 mg/Kg will be injected through a peripheral vein. During laparoscopy, a NIR camera-head (KARL STORZ Gesellschaft Mit Beschränkter Haftung& Co., Tuttlingen, Germany) will be used to visualize the ureteral vascularization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and safety: Clavien-Dindo Classification (from Grade I to V)	Evaluation of feasibility and safety of indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis, considering complications using Clavien-Dindo Classification (from Grade I to V)	From the surgery time, assessed up to 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ureteral vascularization	Evaluation of ureteral vascularization using indocyanine green angiography in women submitted to laparoscopic surgery for endometriosis	Intraoperative

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

General Publications

• Raimondo D, Borghese G, Mabrouk M, Arena A, Ambrosio M, Del Forno S, Degli Esposti E, Casadio P, Mattioli G, Mastronardi M, Seracchioli R. Use of Indocyanine Green for Intraoperative Perfusion Assessment in Women with Ureteral Endometriosis: A Preliminary Study. J Minim Invasive Gynecol. 2021 Jan;28(1):42-49. doi: 10.1016/j.jmig.2020.04.004. Epub 2020 Apr 10.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Endometriosis; Ureters; Indocyanine green angiography
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: ICG and endometriosis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No