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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indocyanine Green arm | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green | Drug | 0.25 mg /(kg BW) Indocyanine Green PULSION® - PULSION Medical Systems were administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of endometriotic lesions | 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) | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Localization of occult endometriotic lesion | To detect occult endometriotic lesions, thanks to the fluorescence of the Indocyanine Green, that would remain otherwise not visible to the surgeon eye | Intraoperative |
| Operatory Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Scambia | Division of Oncologic Gynecology, Fondazione Policlinico Gemelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Sacred Heart | Rome | 00168 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2013 | Oct 25, 2017 |
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In the selected patients, after a first white light visual inspection, 0.25 mg/(kg BW) ICG were injected intravenously. After 5 to 30 minutes a second inspection of the abdomen and pelvis in Near Infrared vision was made. All the visualized lesions were carefully described pre and post the Indocyanine Green injection, removed and listed
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To assess if the use of Indocyanine Green cause a significant increase of the operatory time
| Intraoperative |
| Complications | To assess if the use of Indocyanine Green increase the percentage of intra and post-operative complications | From operatory room up to 3 days |
| Side effects | Evaluation of possible side effects related to the use of Indocyanine Green as a fluorescent endometriosis' marker | From operatory room up to 3 days |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2013 | Oct 25, 2017 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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