Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-100
SponsorUniversity Hospital A Coruña

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • ICG angiography

    Drug

    * 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.

Treatment groups

221 Participants
are divided into 1 treatment group
Group A: Patients undergoing ICG angiography1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity, specificity, and predictive values intraoperatory.

To assess the sensitivity, specificity, and predictive values of VIC angiography for intraoperative detection of skin areas at high risk for necrosis.

Time frame
during surgery
2

Sensitivity, specificity, and predictive values for postoperative complications

To evaluate the sensitivity, specificity, and predictive values of VIC angiography for the prediction of complications during the postoperative period (infection, seroma, hematoma, implant exposure, implant loss, reoperation).

Time frame
up to 1 month

Secondary outcomes

1

Vascularity of nipple areola complex

To assess the presurgical ability of IVC angiography to identify dominant vascularity of the nipple-areola complex.

Time frame
before surgery
2

Surgical planning

To assess the impact of IVC angiography on changing incision planning or surgical pattern.

Time frame
before surgery
3

Time

Identify the time from injection to visualization on the SPY that best predicts necrosis.

Time frame
during surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.