Ambulatory SNP Under Local Anaesthesia in a Subgroup of Breast Cancer Patients - Trial (AMBULANT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Medical Center Alkmaar
Sponsor:
Information provided by (Responsible Party):
M.W.H. Leenders, Medical Center Alkmaar
ClinicalTrials.gov Identifier:
NCT02187718
First received: July 9, 2014
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

Rationale: In breast cancer (BC) patients, lymph node status is a key prognostic indicator. At present, axillary ultrasound (US) with subsequent fine needle aspiration cytology (FNAC) of suspicious lymph nodes (US+FNAC) is widely used as a pre-operative staging method. When US+FNAC is negative, a sentinel node procedure (SNP) is performed during breast surgery. Nowadays, an axillary lymph node dissection (ALND) is generally performed if one of the abovementioned diagnostic entities reveals lymph node metastases. However, the extensive role of ALND in BC patients with lymph node metastases may change or diminish in upcoming years due to emerging evidence that completion ALND (cALND) does not affect disease-free survival and overall survival in early BC patients with (sentinel) node-positive disease. Whether ALND is needed in these patients, should be based on (axillary) tumour load. Because of the fact that tumour load can only be reliably evaluated by SNP and not by US+FNAC, the role of SNP might become even more important in upcoming years.

Ideally, the status of this sentinel lymph node is known prior to breast surgery, so a patient tailored treatment plan can be made and discussed with the patient before breast surgery. In this context, it would be very logical to perform a SNP under local anaesthesia (LA), prior to breast surgery. This might not only lead to significantly less two-step surgical procedures under general anaesthesia (GA), but might also lead to a reduction of depressive symptoms and anxiety and improved quality of life (QoL) of BC patients, because BC patients are in particular risk for psychological distress in the first three months after diagnosis of BC. Knowing lymph node status and the complete treatment plan as soon as possible (by performing a SNP under LA), might reduce this psychological distress. To investigate which BC patients would benefit most from SNP under LA, the investigators recently analysed 1132 BC patients retrospectively. Both prevalence of axillary lymph node metastases and prevalence of false negative results of US+FNAC were directly associated with age <60 years and with primary breast tumour size >20 mm. Hence, these BC patients might benefit most from SNP under LA. In the present study, the value of SNP under LA in these BC patients (i.e. <60 years with a breast carcinoma >20 mm) will be analysed.

Objectives: Reduction of the mean number of operations under general anaesthesia per patient. Improvement of QoL. Reduction of depressive symptoms and experienced anxiety.

Study design: Prospective single centre randomised controlled clinical trial. Study population: Women aged 18 to 60 years who are diagnosed with BC AND with a tumour size of >20 mm ultrasonographically AND with a negative or inconclusive pre-operative US+FNAC.

Intervention: Sentinel Node Procedure under Local Anaesthesia (SNP under LA) Control: Traditional Sentinel Node Procedure under General Anaesthesia (SNP under GA) Main study parameters: Primary outcome parameters are the number of operations under GA per patient and the number of operations under LA per patient. Secondary outcome parameters are QoL, experienced depressive symptoms and anxiety.

Timeline and statistics: The inclusion period will be conducted from the 1st of July 2014 to the 1st of August 2015, and 80 patients will be enrolled in this study (alpha 0.05; power 0.8). Inclusion of 80 patients will be sufficient to reduce the number of two-stage surgical procedures under general anaesthesia with 30%. Data will be analysed using descriptive statistics, Chi-squared test, Fisher's exact test, Mann-Whitney U test, Kruskall-Wallis test, students t-test, ANOVA, paired t-test, Wilcoxon signed-rank test, Friedman test, Pearson's and Spearman's rank correlation coefficients and finally logistic and linear regression analysis.


Condition Intervention
Breast Neoplasms
Procedure: Sentinel Node Procedure under Local Anaesthesia
Procedure: Sentinel Node Procedure under General Anaesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective Single-centre Randomised Controlled Clinical Trial Comparing Sentinel Node Procedure Under Local Anaesthesia to Traditional Sentinel Node Procedure Under General Anaesthesia in Patients <60 Years With a Breast Carcinoma >20 mm.

Resource links provided by NLM:


Further study details as provided by Medical Center Alkmaar:

Primary Outcome Measures:
  • Number of operations under general anaesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of operations under local anaesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The number of patients in whom breast surgery is performed ≤21 days. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Quality of Life is measured with the WHOQOL-bref questionnaire

  • Depressive symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Depressive symptoms are measured with the Centre for Epidemiological Studies-Depression scale (CES-D)

  • Anxiety [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Anxiety is measured with the State-and-Trait-Anxiety-Inventory (STAI)


Other Outcome Measures:
  • Pain during SNP under local anaesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pain during SNP under local anaesthesia is measured with a Numeric Pain Rating Scale

  • Duration of SNP under local anaesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Duration of SNP under general anaesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of lymph nodes excised by SNP under local anaesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of lymph nodes excised by SNP under general anaesthesia [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SNPGA
Sentinel Node Procedure under General Anaesthesia
Procedure: Sentinel Node Procedure under General Anaesthesia
SNPLA
Sentinel Node Procedure under Local Anaesthesia
Procedure: Sentinel Node Procedure under Local Anaesthesia

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Age 18-60 years
  • Diagnosis of invasive BC (established with core needle biopsy of the breast lesion)
  • Breast carcinoma measures > 20 mm ultrasonographically
  • Pre-operative US+FNAC is negative or inconclusive
  • No evidence of distant metastases
  • ASA Classification I-III
  • Signed informed consent

Exclusion Criteria:

  • History of previous breast surgery in the affected breast
  • History of previous axillary surgery in the ipsilateral axilla
  • History of radiation therapy (ipsilateral breast or axilla)
  • History of neo-adjuvant therapy (for the BC)
  • Known allergy to lidocain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02187718

Contacts
Contact: Martijn Leenders, MD +31624271275 m.w.h.leenders@mca.nl
Contact: Hermien Schreurs, MD, PhD +31725484444 w.h.schreurs@mca.nl

Locations
Netherlands
Medical Center Alkmaar Not yet recruiting
Alkmaar, Noord-Holland, Netherlands
Sub-Investigator: Martijn Leenders, MD         
Principal Investigator: Hermien Schreurs, MD, PhD         
Principal Investigator: Anne Roukema, MD, PhD, Prof         
Sub-Investigator: Shirley Go, MD         
Sub-Investigator: Henk-Jan Slooten van, MD, PhD         
Sub-Investigator: Metha Klaver, PhD         
Sub-Investigator: Tjeerd Ploeg, van der, PhD         
Sponsors and Collaborators
Medical Center Alkmaar
Investigators
Principal Investigator: Hermien Schreurs, MD, PhD Medical Center Alkmaar
  More Information

No publications provided

Responsible Party: M.W.H. Leenders, M.W.H. Leenders, M.D., Medical Center Alkmaar
ClinicalTrials.gov Identifier: NCT02187718     History of Changes
Other Study ID Numbers: NL49489.094.14
Study First Received: July 9, 2014
Last Updated: July 10, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Medical Center Alkmaar:
Sentinel Lymph Node Biopsy
Local Anaesthesia

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014