Clinical trial NCT02774785: Does Intra-operative MarginProbe Use Reduce Re-excision Rates?
Official title: Reducing Re-excisions After Breast Conserving Surgery: A Randomized Controlled Trial Comparing the MarginProbe Device in Addition to Standard Operating Procedure Versus Standard Operating Procedure Alone in Preventing Re-excision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2016-05-17
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The new device we are looking at is called the MarginProbe. It is a disposable probe which measures the margins of tissue removed to check they are clear of cancer cells, during breast conservation surgery. After specimen radiology, allows the Surgeon to remove further tissue if necessary, during the same operation if any involved margins are identified. This minimises the need for further repeat operations.

Previous studies carried out elsewhere in the world (USA and Israel) have identified that the probe reduces re-excision rate but there has never been a study in the UK.

The trial involves randomly allocating patients once they are in theatre, to either the MarginProbe procedure after breast conserving surgery and radiology has been completed, or not.

Detailed description: Almost 60% of all patients diagnosed with breast cancer (48000 annually in the UK) undergo breast conserving surgery (BCS. Surgical removal of the cancer aims to reduce the risk of local recurrence and patient mortality. In order to minimise the amount of tissue removed, excision up to the cancer-free area (margins) is undertaken. Further surgery, following initial breast cancer surgery, is required in 25% - 30% of patients because of disease found at the edges of the tissue removed.

Reducing the need for further operations benefits patients (by reducing the number of operations required, improving cosmetic outcome and minimising anxiety) and the NHS (by realising economic benefits).

MarginProbe, a disposable probe which measures the margins of tissue removed during breast cancer surgery, allows the surgeon to remove further tissue during the same surgical procedure to clear any involved margins, minimising subsequent re-operations. Four hundred and sixty patients in 6 specialist Breast Units will be randomly allocated after BCS (and specimen radiology), by telephone randomisation, to either:

* MarginProbe assessment of the surgical specimen with re-excision of margins if required;
* Standard BCS (clinical and radiological clear margins) whereby the wound will be closed and the surgery completed (standard UK practice).

Eligibility criteria: Inclusion Criteria;

* Women aged 18-90 years with DCIS or Invasive Breast cancer containing DCIS diagnosed histopathologically.
* Histologically diagnosed DCIS or invasive lobular cancer in core biopsy (B5a or B5b).
* Tumour size 1.5cm - 4cm and undergoing breast cancer surgery. Written informed consent.

Exclusion Criteria;

* Unsuitable for BCS on basis of tumour size (\<1.5cm or \>4cm) or stage.
* Radiotherapy contraindicated.
* No histopathological evidence of DCIS or invasive lobular cancer.
* Neoadjuvant chemotherapy.

Primary outcomes:
measure: To determine if intraoperative margin assessment after excision of a cancer reduces second operations (reexcision or mastectomy), compared to standard surgical practice by 9 months after primary surgery.
timeFrame: 9 months post surgery
Secondary outcomes:
measure: Quality of Life
timeFrame: 9 months post surgery
measure: EQ5D
timeFrame: 9 months post surgery
measure: To compare the number of patients in both groups presenting with disease free margins greater than 1mm (circumferentially) after breast cancer surgery, using a laboratory histopathological assessment.
timeFrame: 9 months post surgery
measure: Total number of re-excisions
timeFrame: 9 months post surgery
measure: Cosmetic Outcome
timeFrame: 9 months post surgery
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
state: England
Study officials:
References: