Does intraoperative Marginprobe use reduce re-excision rates?

ISRCTN	ISRCTN10169595
DOI	https://doi.org/10.1186/ISRCTN10169595
ClinicalTrials.gov number	NCT02774785
Secondary identifying numbers	19495

Submission date: 20/02/2017
Registration date: 27/03/2017
Last edited: 04/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-reducing-further-operations-after-breast-conserving-surgery

Contact information

Miss Sarah Bowers
Public

Nightingale & Prevent Breast Cancer Centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Phone	+44 161 291 4408
Email	sarah.bowers@mft.nhs.uk

Study information

Study design	Randomised; Interventional; Design type: Prevention, Device, Surgery
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Does intraoperative use of the MarginProbe device reduce the need for further re-excision procedures after conservation surgery for breast cancer?
Study objectives	Study aims: 1. To determine if intraoperative margin assessment after excision of a cancer reduces second operations (re-excision or mastectomy), compared to standard surgical practice by 9 months after primary surgery 2. To determine if the use of the MarginProbe device, after surgical tumour excision and tissue specimen radiography of a breast cancer, reduces rates of further surgical re-excision operations (re-excision or mastectomy), when compared to control/standard practice (whereby the wound is closed after radiography showing clear margins)
Ethics approval(s)	North West/Greater Manchester West REC, 05/06/2015, ref: 15/NW/0306
Health condition(s) or problem(s) studied	Breast cancer
Intervention	All surgeons will perform standard wide local excision (BCS) using localisation of the lesion for impalpable lesions where required. Randomization will take place immediately after the main ex-vivo lumpectomy specimen has been excised, oriented, border marked, inspected, palpated and additional cavity shavings (per visual inspection, palpation and radiology) performed. Patients will be randomised in theatre, by call to the MAHSC CTU, to either standard procedure alone or standard procedure with the use of the MarginProbe device: Device Arm: Measurements shall be taken with the MarginProbe on the outer final surface of each margin. Once the device has been applied to outer final surface of all margins, all margins with one or more positive readings on it should be shaved from the cavity. The procedure will then be concluded in the routine practice. Control Arm: The procedure will be concluded in the routine practice. MarginProbe use starts and ends during the primary lumpectomy procedure. Thus, patient management differs between the two study arms only during the procedure. Following the procedure, pathological assessment and any other patient management aspects are identical for both study arms. The follow-up period for both study arms is 9 months. Follow up visits (month 1, 6 and 9): FACT B +4, HADS and EQ5D Questionnaires and Patient Diary Cards Administered. Photographs for cosmesis completed at baseline and 9 months.
Intervention type	Other
Primary outcome measure	1. Reduction rates in re-excision procedures are determined by review of pathology reports for all participants to record subsequent surgeries at 9 months post initial surgery 2. Total number of re-excision procedures is determined by review of patient notes, clinical data and pathology reports at 9 months post initial surgery 3. Excision margins determined by review of pathology reports at 9 months post initial surgery
Secondary outcome measures	1. Quality of life measured by using validated self-completion disease specific and generic instruments, FACT-B, HADS, health-related utility (EQ5D) and the body image scale of SABIS administered at baseline (pre-surgery) and postal follow-up at 1, 3 and 9 months post-surgery 2. Cosmetic outcome assessment will be performed by two objective evaluators blinded to arm assignment based on pictures taken under standardized photographic conditions. The scoring will be performed using the validated 4-point Harvard scale. Pictures will be taken at baseline and 9 months post-surgery. 3. Impact of margin assessment on patients and carers will be measured by questionnaires assessing experiences and satisfaction and semi structured interviews exploring concerns, expectations, preferences, satisfaction and awareness of procedural differences. This will be a qualitative sub study of the main trial and timescales are dependent on when this is set up. 4. Clinical and cost effectiveness measured by review of hospital in-patient records and patient diary cards at 1, 3 and 9 months
Overall study start date	24/03/2014
Completion date	12/12/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	90 Years
Sex	Both
Target number of participants	Planned Sample Size: 460; UK Sample Size: 460
Total final enrolment	467
Key inclusion criteria	1. Women aged 18-90 years with DCIS or Invasive Breast cancer containing DCIS diagnosed histopathologically 2. Histologically diagnosed DCIS or invasive lobular cancer in core biopsy (B5a or B5b). Invasive lobular carcinoma does not require concomitant DCIS. 3. Tumour size 1.5cm - 4cm and undergoing BCS 4. Written informed consent
Key exclusion criteria	1. Unsuitable for BCS on basis of tumour size (>4cm) or stage. 2. Radiotherapy contraindicated. 3. No histopathological evidence of DCIS or invasive lobular cancer. 4. Small invasive cancers (<1.5cm) 5. Multicentric Disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen 6. Bilateral disease (diagnosed cancer in both breasts) 7. Neoadjuvant systemic therapy 8. Previous radiation in the operated breast 9. Implants in the operated breast 10. Pregnancy 11. Lactation 12. Cryo-assisted localisation 13. Patients who are undergoing full cavity excision following removal of the main lumpectomy specimen during initial lumpectomy procedure.
Date of first enrolment	22/03/2016
Date of final enrolment	31/10/2017

Locations

Countries of recruitment

England
Scotland
United Kingdom

Study participating centres

Wythenshawe Hospital

University Hospital of South Manchester NHS Foundation Trust
The Nightingale Centre and Genesis Prevention Centre
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

St James's University Hospital

Leeds Teaching Hospitals NHS Trust
Bexley Wing
Beckett Street
Leeds
LS9 7TF
United Kingdom

Royal Derby Hospital

Derby Teaching Hospitals NHS Foundation Trust
Lymphoedema and Palliative Medicine
M&G Level 3
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Addenbrookes Hospital

Cambridge University Hospitals NHS Foundation Trust
NIHR CRN Eastern
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Western General Hospital

NHS Lothian
Edinburgh Breast Unit
Edinburgh
EH4 2XU
United Kingdom

Macclesfield District General Hospital

Cancer Resource Centre
Victoria Road
Macclesfield
SK10 3BL
United Kingdom

The Royal Bournemouth and Christchurch Hospitals

Castle Ln E
Bournemouth
BH7 7DW
United Kingdom

Sponsor information

University Hospital of South Manchester
Hospital/treatment centre

Southmoor Road
Manchester
M23 9LT
England
United Kingdom

Phone	+44 161 291 4045
Email	sian.hannison@manchester.ac.uk
"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/09/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal with intention to publish the findings from the trial approximately 1 year after trial closure.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from nigel.bundred@manchester.ac.uk

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 3.3	11/01/2019	04/10/2022	No	No
HRA research summary			28/06/2023	No	No

Additional files

33259 MarginProbe protocol v3.3 11Jan2019.pdf

Editorial Notes

04/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
28/09/2021: The study contact has been updated.
11/06/2021: The intention to publish date has been changed from 30/06/2021 to 30/09/2021.
09/12/2020: ClinicalTrials.gov number and total final enrolment added.
23/03/2020: The following changes have been made:
1. The overall trial end date has been changed from 30/06/2018 to 12/12/2020.
2. The intention to publish date has been changed from 30/06/2019 to 30/06/2021.
24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates.
10/04/2017: Link to Cancer Help UK lay summary added to plain English Summary field

Does intra­operative Marginprobe use reduce re­-excision rates?