Prospective Evaluation of Near-infrared Fluorescence Imaging Use as a Supportive Tool in Deep Infiltrating Endometriosis Surgery
Condition: Pelvic Endometriosis; Endometriosis Outside Pelvis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

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
      neo-vascularization, could facilitate the localization and excision of endometriotic lesions
      exploiting the hypervascularization due to the chronic inflammation. The already published
      Pilot Study GRE-ENDO (Cosentino F, Near-Infrared Imaging with Indocyanine Green for Detection
      of Endometriosis Lesions (Gre-Endo Trial): A Pilot Study.), encouraged the effort of a larger
      prospective trial. Based on the mini-max two-stage design by Simon [Simon R. Optimal two
      stage design for phase II clinical trials], the investigators tested the null hypothesis that
      the true rate of pathologically assessed endometriosis would improve from 87% to the
      clinically relevant alternative of 100.0%, as assessed by NIR-ICG laparoscopy.
    

Detailed description: 
      Patients were recruited within the clinical routine after indication for laparoscopy under
      consideration of the inclusion and exclusion criteria.

      The sample size was calculated according to the study design by Simon (Simon R. Optimal two
      stage design for phase II clinical trials), using an α-error of 0.01 (two-sided) and a
      β-error of 0.90. Considering a patient dropout of approximately 10%, the study was planned to
      enrol at least 47 women.

      The first abdominal and pelvi's inspection was made using direct laparoscope visualization
      under white light conditions. All areas suspected of peritoneal endometriosis was 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 them
      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.
    

Intervention name(s): Indocyanine Green
Intervention type(s): Drug
Intervention description(s): 0.25 mg /(kg BW) Indocyanine Green PULSION®/ VERDYE Diagnostic Green®
- Indocyanine Green is administered Intravenously
Intervention model: Single Group Assignment
Intervention model description: In the selected patients, after a first white light visual inspection, 0.25 mg/(kg BW) ICG were injected intravenously. After 15 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
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: indocyanine Green; deep Infiltrating Endometriosis; near-Infrared Vision; occult endometriosis; invisible endometriosis