Trial Title:
Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery
NCT ID:
NCT05910931
Condition:
Skin Necrosis
Complication
Conditions: Official terms:
Necrosis
Conditions: Keywords:
breast cancer
oncoplastic surgery
breast reconstruction
skin sparing mastectomy
nipple-skin sparing mastectomy
indocyanine color green
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
ICG angiography
Description:
- A first injection with the patient asleep before starting the intervention to
visualize the vascular anatomy of each patient and assess the pedicles and
incisions.
- A second bolus after breast resection to assess the viability of skin flaps and
glandular pedicles.
- A third injection to obtain an angiography after implant placement and wound
closure.
For angiography, the SPY System with the SPY-Q software will be used.
Arm group label:
Patients undergoing ICG angiography
Summary:
During the performance of oncoplastic surgery and skin-sparing or skin-nipple mastectomy
there is a significant loss in the perfusion of the cutaneous envelope of the breast,
which can produce areas of vascular suffering of the skin that sometimes cause necrosis
of the same. Skin necrosis is the most important adverse event in oncoplastic and
reconstructive surgery of the breast, since it causes delays in adjuvant treatments to
surgery, worsening of the cosmetic result, and, on occasions, loss of the implant and
reconstruction.
Indocyanine color green (ICG) angiography has been proposed as a diagnostic alternative
to determine the vascular perfusion of the skin envelope of the breast during surgery,
which would allow the removal of tissue at risk of necrosis to avoid this complication
during the postoperative period. However, the scientific literature does not currently
allow an adequate assessment of this diagnostic procedure due to the absence of
prospective studies that have evaluated its sensitivity, specificity, and predictive
values.
The objective of this prospective study is to evaluate ICG angiography of skin flaps of
the breast and the surgeon's decision in women with breast cancer or at high risk for
breast cancer undergoing oncoplastic surgery or mastectomy with the help of skin or
skin-nipple. Based on the results of this study, the sensitivity, specificity, and
predictive values of this technique for the prediction of adverse events during the
postoperative period will be established.
Detailed description:
Currently, surgery is a decisive therapeutic element in the management of women with
breast cancer and at high risk for breast/ovarian cancer. In the first scenario,
oncological surgery has evolved towards more complex technical procedures, such as
oncoplastic surgery or skin-nipple-sparing mastectomies. These procedures have improved
the quality of breast conservation or breast reconstruction, but have also increased the
incidence of postoperative complications. In the second scenario, risk reduction
mastectomies also share this same problem with an increase in adverse events after the
use of ultra-conservative mastectomies. Without a doubt, skin necrosis is the most
significant adverse event during the postoperative period in these patients due to three
reasons. The first focuses on patients with breast cancer in whom skin necrosis delays
the start of adjuvant treatments to surgery, chemotherapy or radiotherapy, causing
greater complexity in their care process. Secondly, a significant number of these women
with skin necrosis will require a second surgery to close the defect in the skin
coverage, generally using a local flap, increasing care saturation and healthcare costs.
Finally, these skin necrosis generate anatomical defects that in many cases will lead to
cosmetic sequelae, worsening satisfaction and quality of life in this group of women.
These consequences are especially relevant in women with prepectoral breast
reconstruction, since the absence of muscle between the skin and the implant facilitates
the exposure of the latter and, on occasions, the loss of the reconstruction.
During the last 15 years our unit has published various articles analyzing adverse events
during the postoperative period in patients with oncoplastic, reconstructive and risk
reduction surgery. Thus, in a comparative study between lumpectomy and oncoplastic
surgery in patients in our unit, an incidence of skin necrosis of 2.5% was demonstrated
in oncoplastic procedures compared to 0.1% in lumpectomy. This higher incidence of
complications had a significant impact on the delay for the start of radiotherapy,
increasing this delay by 10 days compared to the group with lumpectomy. In the context of
mastectomy, our unit has recently published the results of its prospective study PreQ 20
and it has shown an incidence of 5.6% of necrosis and skin dehiscence in women with
skin-sparing mastectomy and breast cancer. Finally, another prospective study identified
technical complexity and the appearance of postoperative complications as the two
variables related to the appearance of cosmetic sequelae during follow-up in patients in
our unit. These results highlight the value of prevention and/or early identification of
skin ischemia to reduce the rate of necrosis during the postoperative period, guarantee
delays during the care process, reduce cosmetic sequelae, and increase satisfaction and
quality of life for women. with breast cancer and/or at high risk.
Various studies have evaluated ICG angiography as a diagnostic method in mastectomy skin
flap perfusion. To our knowledge, only two nonrandomized prospective studies have
evaluated the sensitivity, specificity, and predictive values of this technique. The
study by Phillips et al evaluated this procedure in 51 immediate reconstructions with
expanders for the prediction of postoperative skin necrosis. Sensitivity, specificity,
positive (PPV) and negative (NPV) predictive value were 90%, 50%, 56% and 88%,
respectively. On the other hand, in the study by Munabi et al these values were 88%, 83%,
44% and 98%, respectively. In this latter study the authors found that smoking and
epinephrine injection decreased the specificity of this diagnostic method from 98% to
83%. These studies have two limitations. The first refers to the fact that they have been
performed in patients with a retropectoral breast reconstruction and through the use of
expanders. Currently this type of reconstruction has been replaced by prepectoral
reconstruction with direct implantation and for this reason we lack information on this
new surgical modality. On the other hand, there are no studies that have evaluated ICG
angiography in women with oncoplastic procedures.
A Cochrane Library review was recently published whose objective was to evaluate the
capacity of ICG angiography for the prevention of necrosis in mastectomy skin flaps in
women undergoing immediate reconstruction after skin-sparing mastectomy. In this review
we found nine studies that compared the number of postoperative complications in women
undergoing ICG breast skin assessment versus clinical assessment. In these studies, a
total of 1,589 women with 2,199 breast reconstructions were evaluated, and the number of
complications per patient or per breast was reported. The main patient-related results of
this review were that:
- ICG can reduce reoperation rates.
- there is uncertainty as to whether ICG decreases the rates of mammary skin necrosis,
infection, hematoma and seroma.
The main results referring to the breast were:
- ICG can reduce mammary skin necrosis, reoperation rates and infection.
- there is uncertainty as to whether ICG has an effect on hematoma and seroma rates.
The evidence from the studies evaluated during this review is considered to be of
very low quality as there are no prospective randomized studies. This review
emphasizes the need for prospective studies to further investigate the use of the
ICG in oncoplastic and reconstructive surgery of the breast.
These uncertainties have encouraged us to carry out this prospective study in order to
evaluate the role of indocyanine green angiography in the intraoperative identification
of skin areas at risk for the appearance of necrosis in the skin cover of the breast in
women operated on by an immediate oncoplastic or reconstructive procedure. Usually, when
we talk about a diagnostic procedure such as ICG angiography, its sensitivity,
specificity, positive predictive value, and negative predictive value are described.
These parameters reflect the characteristics of the diagnostic test and serve to decide
when they should be used (sensitivity and specificity of the test) or what is the meaning
of this test in a particular patient. Unfortunately, the scientific literature has not
evaluated these parameters for ICG angiography in the context of prepectoral
reconstruction and oncoplastic surgery, which leads to empirical use of this procedure.
The ultimate goal of this study is to provide information on the sensitivity,
specificity, and predictive values of ICG angiography in these two clinical settings.
With this, we intend to identify those patients in whom this diagnostic procedure
provides added value in their surgical planning, reducing the incidence of skin necrosis
and other associated surgical complications.
Criteria for eligibility:
Study pop:
Women operated on for breast cancer or risk-reducing surgery who underwent oncoplastic
surgery or skin-sparing mastectomy were included. The study aims to assess the
sensitivity and specificity of indocyanine color green to predict skin necrosis
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
The study population includes two type of patients:
- Women who underwent oncoplastic procedures for breast conservation. This group is
made up of women with breast cancer in whom the Breast Unit tumor committee
recommended a breast-conserving surgical procedure. The techniques included for this
study are vertical mammoplasty, horizontal mammoplasty, and local flaps by
displacement or rotation.
- Women undergoing a skin or skin/nipple-sparing mastectomy with immediate breast
reconstruction. This group is made up of patients with a diagnosis of breast
carcinoma, who require a mastectomy as surgical treatment, as well as those
high-risk women whose mastectomy is aimed at reducing the risk of breast cancer. The
surgical techniques included in this group are Carlson type 1, 2, 3 and 4
skin-sparing mastectomies and nipple and skin-sparing mastectomies using
inframammary and vertical approaches. In all patients, the type of breast
reconstruction will be the placement of a definitive implant in the prepectoral
position.
Exclusion Criteria:
- Women with iodine allergy or thyroid disease are excluded from this study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Abente y Lago
Address:
City:
A Coruña
Zip:
15001
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Alejandra García Novoa, MD PhD
Phone:
0034 981178000
Email:
maria.alejandra.garcia.novoa@sergas.es
Start date:
June 1, 2023
Completion date:
July 31, 2025
Lead sponsor:
Agency:
University Hospital A Coruña
Agency class:
Other
Source:
University Hospital A Coruña
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05910931
