Diagnostic Value of ICG in Endometriosis

Endometriosis Clinical Trial

Official title:

Visualization of Peritoneal Endometriosis With 2D-Laparoscopy and Indocyanine Green

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850158
• Other study ID #: Study ID 3300
• Status: Completed
• Phase: Early Phase 1
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Indocyanine Green (ICG)
• Laparoscopy
• Near Infrared Fluorescence Imaging

Intervention

Drug:
• Indocyanine Green
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.

Locations

Country	Name	City	State
Switzerland	Department of Obstetrics and Gynecology, University Hospital of Bern, Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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