Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06347952 |
Other study ID # |
SE1188 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 27, 2022 |
Est. completion date |
January 29, 2024 |
Study information
Verified date |
March 2024 |
Source |
Royal Marsden NHS Foundation Trust |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Despite breast cancer being one of the most frequent affecting women worldwide, it is also
one of the most curable. Its multimodality treatment is based on surgery, radiotherapy and
systemic therapy.
Breast conservation has evolved thanks to the utilization of mammoplasty techniques to
achieve better aesthetic results - known collectively as 'oncoplastic' when applied to cancer
surgery.
The key considerations in oncoplastic surgery are: tumour characteristics (extent, location)
and reconstituting the aesthetically acceptable breast shape as well as nipple-areola complex
(NAC) preservation. The former is vital to achieve clear resection margins to optimise local
control. Planning is aided by imaging with ultrasound, mammography and often MRI. NAC
preservation is a priority and expectation of patients and surgeons alike developed in the
field of aesthetic breast surgery by plastic surgeons.
The attachment of any structure to the body by its nourishing blood supply (arteries and
veins) is known as a 'pedicle'. The anatomy of the pedicle and its preservation is key to
preservation of the NAC which has a well understood blood supply albeit with variations
across patients and well-described patterns (ref). To preserve the NAC as part of a cancer
resection and aesthetic breast re-shaping, a pedicle must be fashioned and the NAC
successfully re-positioned to restore the aesthetic balance of the newly shaped (and often
lifted) breast.
The aim of this study is to determine if by use of doppler (acoustic or colour flow
modalities) to map the blood vessels supplying the NAC (for each individual patient),
surgeons and trainees can construct a safe pedicle with greater confidence and ease, reducing
the concern about diminishing its blood supply which could lead to NAC necrosis and loss. We
would like to study the nipple blood supply as it pertains to each patient before surgery
using acoustic doppler (AD) and colour doppler imaging (CDI). Each modality has its strengths
and weaknesses and this evaluation aims to assess the contribution of each.
The most challenging part of therapeutic mammoplasty is the pre-operative planning. The
surgeon must consider (1) localization of the tumour location and extent, (2) re-shaping of
the remaining breast parenchyma and (3) placement of the vascularized the NAC and pedicle.
Several studies have been done regarding NAC vascularization and its variation between not
only each person, but also each side (right versus left). Most studies were on cadavers3, MRI
4or CT angiography5. On the other hand, Seitz et al6 pointed out the predominancy of the NAC
vascularization based on preoperative MRI in the breast without cancer. Specifically, they
split all 56 breasts into 5 categories: type I medial, type II lateral, type III central,
type IV inferior, and type V mixed. Moreover, they highlighted that the majority of NACs were
supplied mostly by medial vessels. Basaran et al7 evaluated sixteen patients with severe
gigantomastia and they marked the vessel locations before surgery by using Doppler
ultrasonography.
Given the variation between people and their breasts, in this SE we would like to map
preoperatively the NAC vascularization to understand if it could assist the surgeon's plan or
even enable them to modify the NAC pedicle design. The mapping will be done by both CDI and
AC. We will use both techniques to understand if there will be any difference in their
accuracy and to determine if 1 modality alone will suffice.
Whilst both methods (acoustic and colour flow doppler) are used selectively in cases by some
surgeons, this SE will specifically if routine use incorporated into the procedure will
systematically facilitate pedicle design. The doppler carries no risk to the patient and is
considered a tool to facilitate surgery rather than an intervention beyond standard of care.
Specifically, acoustic doppler (AC) - is a hand-held device, easy to use intra-operatively
which gives an audible signal in real-time to enable marking of the exact location of a blood
vessel at a given point (or along a specified line) within the tissue / under the skin.
Colour doppler imaging (CDI) will additionally give visual information which includes the
calibre and depth of the vessel and enables the entire course of the vessel and any
connections to be mapped relatively easily.
In reality, when the design and shaping of the NAC pedicle is undertaken during the
operation, ideal placement / movement of this structure may be restricted by the surrounding
tissue attachments which the surgeon may be fearful of dividing in case a critical artery is
divided in the process (compromising the NAC perfusion). Knowing the exact location of the
artery will give the surgeon confidence in knowing how far such tissue mobilisation can be
safely undertaken.
Some therapeutic mammoplasties also involve creation of a 'secondary pedicle' which consists
of breast tissue - again mobilised on a pedicle which must be moved within the breast to fill
a defect created by the cancer resection. A secondary aim of this SE will be to map the
principle arteries which supply that tissue as well.
In summary, this SE aims to establish the benefits of an ad-hoc practice by careful
documentation of consecutive cases prospectively during surgery for mammoplasty where NAC or
secondary pedicle mobilisation is required.