Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05910931 |
| Other study ID # |
gBreast 22 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
June 2023 |
| Source |
University Hospital A Coruña |
| Contact |
Benigno Acea Nebril, MD PhD |
| Phone |
0034 981178000 |
| Email |
benigno.acea.nebril[@]sergas.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
