Objective: Using near-infrared fluorescence (NIRF) with a Karl Storz® NIR fluorescence laparoscope to provide a real-time intra-operative enhanced visualization of endometriosis during diagnostic laparoscopy. Thus improving identification of…
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Investigate the feasibility of identification
of endometriotic lesions with (conventional non-robotic) fluorescence
laparoscopy equipment with preoperative or peroperative ICG administration.
Assessment will be performed using an intraoperative registration form (see
attachment), postoperative video-analysis (with determination of the
target-to-background ratio) and with histological confirmation. Biopsies will
be taken from suspicious endometriotic areas seen with both the conventional
white light mode and NIRF-mode, areas that appear only with white light mode
or NIRF-mode and areas without any visible or fluorescent areas. Histologic
examination is carried out on the biopsies to confirm the diagnosis.
Secondary outcome
-
Background summary
Rationale:
Endometriosis, defined as the presence of endometrial tissue outside the
uterine cavity, is a common disease affecting 10-15% of women of reproductive
age and up to 90% of women with pelvic pain. The gold standard for diagnosis of
endometriosis is the combination of laparoscopy with histological confirmation.
However, during laparoscopy using conventional white light imaging,
endometriotic lesions can appear red and vascular, white and scarred, black,
brown, yellow, or almost any colour, thus making it difficult to identify .
Our hypothesis is that the use of indocyanine green-based (ICG) fluorescence
imaging during laparoscopy will provide a real-time intraoperative image
enhancement for detection of endometriotic lesions by using the hypervascular
characteristic of this disease.
Study objective
Objective: Using near-infrared fluorescence (NIRF) with a Karl Storz® NIR
fluorescence laparoscope to provide a real-time intra-operative enhanced
visualization of endometriosis during diagnostic laparoscopy. Thus improving
identification of endometriosis for complete resection of the affected areas
and increasing efficiency of the procedure.
Study design
Study design: A prospective observational pilot study.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients will receive intraoperative injections
of ICG in addition to the standard care. Moreover, biopsies will be taken to be
sent for histological confirmation of endometriosis and normal tissue. The
biopsies taken from sites that are visible with conventional white light are a
part of the standard procedure. However, additional biopsies may be taken at
sites that appear only after injection of the dye. Furthermore, a biopsy will
be taken from the sites not showing any suspicious lesions in both modes as a
negative control sample. These will be the additional (minimally) invasive
actions for the patient. The last 5 patients to be included, will receive the
administration of ICG prior to surgery, simultaneously with the induction of
anesthesia.
Initially, patients participating in this study will not benefit from the
application of NIRF during the surgical procedure. The laparoscopic
fluorescence imaging system itself is not related to any kind of additional
risk for the patient.
boschstraat 105E
Maastricht 6211AW
NL
boschstraat 105E
Maastricht 6211AW
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
Patients scheduled for elective laparoscopic surgery in which endometriosis is suspected or proven
Able to understand the nature of the study and what will be required of them
Females
Age >18years
Premenopausal
No history of impaired liver and renal function
No history of hypersensitivity or allergy to indocyanine green
Willing to participate
Exclusion criteria
Not able to give written informed consent
Males
Aged < 18 years
Pregnant or breast-feeding women
Known indocyanine green hypersensitivity or allergy
Not willing to participate
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54458.068.15 |