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Mapping Arterial Perforators Within the Breast During Mammoplasty

NCT06347952 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2024-04-04

No results posted yet for this study

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

Interventions

PROCEDURE

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

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).

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Peter A Barry, MPhil, FRACS · Royal Marsden NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2024-01-25
Completion
2024-01-29

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06347952 on ClinicalTrials.gov