Indocyanine Green and Near-Infrared Vision for Detection of Endometriosis (GRE-Endo Trial)
Overview
- Phase
- Phase 2
- Intervention
- Indocyanine Green
- Conditions
- Pelvic Endometriosis
- Sponsor
- Catholic University of the Sacred Heart
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Detection of endometriotic lesions
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The aim of the study is to establish a new and more accurate method to visualize the peritoneal changes caused by endometriosis using Indocyanine Green mediated fluorescence imaging. The hypothesis is that Indocyanine Green, a fluorescent dye that has wide applications throughout medicine in identifying vascularity of tissues and neovascularization, could facilitate the localization and excision of endometriotic lesions exploiting the hypervascularization due to the chronic inflammation
Detailed Description
Patients were recruited within the clinical routine after indication for laparoscopy under consideration of the inclusion and exclusion criteria. The first abdominal and pelvi's inspection was made using direct laparoscope visualization under white light conditions. All areas suspected of peritoneal endometriosis were classified as white, black and red lesions and recorded together with their anatomic location in the surgical record for the purposes of subsequent extirpation. After the first visual inspection the patient was administered with 0.05 - 0.25 mg /(kg BW) Indocyanine Green intravenously. The Indocyanine Green imaging mode of the Olympus Indocyanine Green Imaging System was activated and suspected areas in Indocyanine Green imaging mode were recorded with their corresponding appearance in white light mode. If suspected areas were visible either in white light or Indocyanine Green imaging mode, specific sample has been taken from these areas. In addition control biopsy specimens from inconspicuous peritoneum has been taken.
Investigators
Prof. Giovanni Scambia
Professor
Catholic University of the Sacred Heart
Eligibility Criteria
Inclusion Criteria
- •Suspected endometriosis with necessity for laparoscopic confirmation and resection
- •Regular menstrual cycles
Exclusion Criteria
- •Patients younger than 18 years and older than 50 years at time of operation
- •Subject with previous history of adverse reaction or allergy to Indocyanine Green, iodine, shellfish or iodine dyes
- •Documented allergy to sulfur containing compounds
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Indocyanine Green
- •Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests (Total bilirubin increased by factor 1.5 than normal and/or serum glutamic oxaloacetic transaminase increased by factor 2 than normal)
- •Subject has uremia, serum creatinine (\> 2.0 mg/dl)
- •Subject has severe coronary heart disease (instable angina pectoris)
- •Pregnant or breast-feeding women
- •Subject actively participating in another drug, biologic and/or device protocol
- •The presence of medical conditions contraindicating general anesthesia or standard surgical approaches
Arms & Interventions
Indocyanine Green arm
All the enrolled patients met the inclusion criteria. No patients have been excluded from the study. All patient have been subjected, during laparoscopy, to an accurate inspection of the abdomen and all the visible endometriotic lesions have been described. Subsequently, 0.25 mg /(kg BW) Indocyanine Green were administered intravenously during surgery and a second look of the abdomen and pelvis with the Near Infrared Vision has been made, in order to identify the fluorescent lesions. All the lesions has been described and localized pre and post the Indocyanine Green injection and then removed and properly cataloged
Intervention: Indocyanine Green
Outcomes
Primary Outcomes
Detection of endometriotic lesions
Time Frame: Intraoperative
Optical qualitative assessment through the visual evaluation of a single expert surgeon (presence / absence of fluorescence, due to the injection of the Indocyanine Green and the use of the Near Infrared vision, at the level the of suspected endometriotic lesions)
Secondary Outcomes
- Localization of occult endometriotic lesion(Intraoperative)
- Operatory Time(Intraoperative)
- Complications(From operatory room up to 3 days)
- Side effects(From operatory room up to 3 days)