Mapping Arterial Perforators Within the Breast During Mammoplasty

NCT06347952 | Completed

• 1 other identifier: SE1188
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer surgery can often be carried out as part of a breast reduction procedure known as 'therapeutic mammoplasty'. Where a woman has a breast with adequate volume, even larger cancers can be removed in an aesthetically acceptable way with re-shaping of the breast (often reduction and lift) incorporated into the cancer removal. An expectation and desire for most women is that the nipple and areola (known as the 'nipple-areolar complex' or NAC) is not only preserved, but re-positioned (usually lifted) to re-balance the overall aesthetic result. In moving the NAC, the surgeon must ensure an adequate blood supply is maintained to preserve nourishment of the NAC tissue otherwise it can die (necrose) resulting in its removal. The tissue carrying the blood supply is known as a 'pedicle' and is fashioned by the surgeon for each patient during surgery. We know as surgeons, that in most areas of anatomy of the human body there are variations in the pattern of blood vessels. The NAC blood supply is no exception. Yet for each individual patient, the only way to safely know these anatomical patterns is to map them before or during surgery. A surgical tool utilising an aspect of ultrasound (known as doppler) is often used to locate visually (or by hearing) blood flow from blood vessels in operations where such knowledge is critical to the success of the procedure (for example DIEP-based breast reconstruction or chest wall perforator flaps). We would like to evaluate the effectiveness of the routine use of doppler for NAC preservation during mammoplasty procedures to see if it gives the consultant surgeon and/or trainee a greater degree of confidence when shaping the NAC pedicle to preserve its blood supply. In addition, we evaluate the training potential of patients undergoing symmetrising breast reduction, whereby the tissue removed is first mapped using acoustic doppler as for the NAC above.

Conditions

Breast Cancer

Keywords

oncoplastic surgery; therapeutic mammoplasty; breast reduction for cancer

Outcome Measures

Primary Outcomes (1)

• Full-thickness (complete or partial) necrosis of nipple-areolar complex

  Any amount (as witnessed clinically) of full-thickness necrosis of the nipple-areolar complex of either breast in patients who have undergone breast reduction (for cancer - on the cancer side or matching reduction side)

  Within 30 days after surgery

Interventions

Use of Acoustic and color imaging doppler during surgery for breast cancer PROCEDURE

The intervention (post pilot study) is to systematically record the effect of routine use of acoustic as well as color imaging doppler during mammoplasty for breast cancer (for both the therapeutic and symmetrising breast reduction).

Eligibility Criteria

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

Study Population

A prospective single-centre cohort study on consecutive patients diagnosed with primary breast cancer undergoing either therapeutic or symmetrising mammoplasty (Wise or vertical scar pattern) or both. Inclusion criteria were female patients \>18 years age and plan for construction of at least 1 (i.e. unilateral / bilateral) NAC pedicle based on the superficial branches of either the 2nd (superior), 3rd (medial) anterior intercostal, the lateral thoracic (lateral) arteries or a combination thereof.

You may qualify if:

• female patients \>18 years age
• plan for construction of at least 1 (i.e. unilateral / bilateral) NAC pedicle based on the superficial branches of either the 2nd (superior), 3rd (medial) anterior intercostal, the lateral thoracic (lateral) arteries or a combination thereof.

You may not qualify if:

• Patients planned solely for inferior NAC pedicle reduction mammoplasty
• patients planned for bilateral nipple/NAC sacrifice

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter A Barry, MPhil, FRACS

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: April 27, 2022
• Primary Completion: January 25, 2024
• Study Completion: January 29, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-03

Locations

GB (1)