Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05910931
Status:
RECRUITING
Last Update Posted:
2023-06-20
First Post:
2023-06-04
Brief Title:
Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery
Sponsor:
University Hospital A Coruña
Organization:
University Hospital A Coruña
Study Overview
Official Title:
Prospective Study for the Evaluation of the Efficacy and Concordance of Angiography With Indocyanine Green in the Identification of Complications After Oncoplastic Surgery and Skin and Nipple-skin Sparing Mastectomy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 surgeons 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
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 surgeons 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 breastovarian 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 25 was demonstrated in oncoplastic procedures compared to 01 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 56 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 andor 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 andor 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 1589 women with 2199 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
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 25 was demonstrated in oncoplastic procedures compared to 01 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 56 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 andor 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 andor 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 1589 women with 2199 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None