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

NCT05910931 | Recruiting FDA Drug

• 1 other identifier: gBreast 22
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Skin Necrosis; Complication

Keywords

breast cancer; oncoplastic surgery; breast reconstruction; skin sparing mastectomy; nipple-skin sparing mastectomy; indocyanine color green

Outcome Measures

Primary Outcomes (2)

• 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.

  during surgery

• 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).

  up to 1 month

Secondary Outcomes (3)

• Vascularity of nipple areola complex

  before surgery

• Surgical planning

  before surgery

• Time

  during surgery

Study Arms (1)

Patients undergoing ICG angiography

All women operated on in the breast unit who require a reduction mammoplasty, a skin-sparing mastectomy (or skin and nipple) with immediate reconstruction and local flaps for remodeling or implant coverage.

Drug: ICG angiography

Interventions

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.

Patients undergoing ICG angiography

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• 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.

You may not qualify if:

• \- Women with iodine allergy or thyroid disease are excluded from this study.

Sponsors & Collaborators

• University Hospital A Coruña: lead

Study Sites (1)

Hospital Abente y Lago

A Coruña, 15001, Spain

RECRUITING

MeSH Terms

Conditions

Necrosis; Breast Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Benigno Acea Nebril, MD PhD

  University Hospital A Coruña

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benigno Acea Nebril, MD PhD

CONTACT

0034 981178000; benigno.acea.nebril@sergas.es

Alejandra García Novoa, MD PhD

CONTACT

0034 981178000; maria.alejandra.garcia.novoa@sergas.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Breast Surgeon

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 20, 2023
• Study Start: June 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)