<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02187718</url>
  </required_header>
  <id_info>
    <org_study_id>NL49489.094.14</org_study_id>
    <nct_id>NCT02187718</nct_id>
  </id_info>
  <brief_title>Ambulatory SNP Under Local Anaesthesia in a Subgroup of Breast Cancer Patients - Trial</brief_title>
  <acronym>AMBULANT</acronym>
  <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 &lt;60 Years With a Breast Carcinoma &gt;20 mm.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Center Alkmaar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical Center Alkmaar</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: In breast cancer (BC) patients, lymph node status is a key prognostic indicator.&#xD;
      At present, axillary ultrasound (US) with subsequent fine needle aspiration cytology (FNAC)&#xD;
      of suspicious lymph nodes (US+FNAC) is widely used as a pre-operative staging method. When&#xD;
      US+FNAC is negative, a sentinel node procedure (SNP) is performed during breast surgery.&#xD;
      Nowadays, an axillary lymph node dissection (ALND) is generally performed if one of the&#xD;
      abovementioned diagnostic entities reveals lymph node metastases. However, the extensive role&#xD;
      of ALND in BC patients with lymph node metastases may change or diminish in upcoming years&#xD;
      due to emerging evidence that completion ALND (cALND) does not affect disease-free survival&#xD;
      and overall survival in early BC patients with (sentinel) node-positive disease. Whether ALND&#xD;
      is needed in these patients, should be based on (axillary) tumour load. Because of the fact&#xD;
      that tumour load can only be reliably evaluated by SNP and not by US+FNAC, the role of SNP&#xD;
      might become even more important in upcoming years.&#xD;
&#xD;
      Ideally, the status of this sentinel lymph node is known prior to breast surgery, so a&#xD;
      patient tailored treatment plan can be made and discussed with the patient before breast&#xD;
      surgery. In this context, it would be very logical to perform a SNP under local anaesthesia&#xD;
      (LA), prior to breast surgery. This might not only lead to significantly less two-step&#xD;
      surgical procedures under general anaesthesia (GA), but might also lead to a reduction of&#xD;
      depressive symptoms and anxiety and improved quality of life (QoL) of BC patients, because BC&#xD;
      patients are in particular risk for psychological distress in the first three months after&#xD;
      diagnosis of BC. Knowing lymph node status and the complete treatment plan as soon as&#xD;
      possible (by performing a SNP under LA), might reduce this psychological distress. To&#xD;
      investigate which BC patients would benefit most from SNP under LA, the investigators&#xD;
      recently analysed 1132 BC patients retrospectively. Both prevalence of axillary lymph node&#xD;
      metastases and prevalence of false negative results of US+FNAC were directly associated with&#xD;
      age &lt;60 years and with primary breast tumour size &gt;20 mm. Hence, these BC patients might&#xD;
      benefit most from SNP under LA. In the present study, the value of SNP under LA in these BC&#xD;
      patients (i.e. &lt;60 years with a breast carcinoma &gt;20 mm) will be analysed.&#xD;
&#xD;
      Objectives: Reduction of the mean number of operations under general anaesthesia per patient.&#xD;
      Improvement of QoL. Reduction of depressive symptoms and experienced anxiety.&#xD;
&#xD;
      Study design: Prospective single centre randomised controlled clinical trial. Study&#xD;
      population: Women aged 18 to 60 years who are diagnosed with BC AND with a tumour size of &gt;20&#xD;
      mm ultrasonographically AND with a negative or inconclusive pre-operative US+FNAC.&#xD;
&#xD;
      Intervention: Sentinel Node Procedure under Local Anaesthesia (SNP under LA) Control:&#xD;
      Traditional Sentinel Node Procedure under General Anaesthesia (SNP under GA) Main study&#xD;
      parameters: Primary outcome parameters are the number of operations under GA per patient and&#xD;
      the number of operations under LA per patient. Secondary outcome parameters are QoL,&#xD;
      experienced depressive symptoms and anxiety.&#xD;
&#xD;
      Timeline and statistics: The inclusion period will be conducted from the 1st of July 2014 to&#xD;
      the 1st of August 2015, and 80 patients will be enrolled in this study (alpha 0.05; power&#xD;
      0.8). Inclusion of 80 patients will be sufficient to reduce the number of two-stage surgical&#xD;
      procedures under general anaesthesia with 30%. Data will be analysed using descriptive&#xD;
      statistics, Chi-squared test, Fisher's exact test, Mann-Whitney U test, Kruskall-Wallis test,&#xD;
      students t-test, ANOVA, paired t-test, Wilcoxon signed-rank test, Friedman test, Pearson's&#xD;
      and Spearman's rank correlation coefficients and finally logistic and linear regression&#xD;
      analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of operations under general anaesthesia</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of operations under local anaesthesia</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of patients in whom breast surgery is performed ≤21 days.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of Life is measured with the WHOQOL-bref questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>6 months</time_frame>
    <description>Depressive symptoms are measured with the Centre for Epidemiological Studies-Depression scale (CES-D)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>6 months</time_frame>
    <description>Anxiety is measured with the State-and-Trait-Anxiety-Inventory (STAI)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain during SNP under local anaesthesia</measure>
    <time_frame>6 months</time_frame>
    <description>Pain during SNP under local anaesthesia is measured with a Numeric Pain Rating Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of SNP under local anaesthesia</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Duration of SNP under general anaesthesia</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of lymph nodes excised by SNP under local anaesthesia</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of lymph nodes excised by SNP under general anaesthesia</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>SNPGA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sentinel Node Procedure under General Anaesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SNPLA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Sentinel Node Procedure under Local Anaesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sentinel Node Procedure under Local Anaesthesia</intervention_name>
    <arm_group_label>SNPLA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sentinel Node Procedure under General Anaesthesia</intervention_name>
    <arm_group_label>SNPGA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age 18-60 years&#xD;
&#xD;
          -  Diagnosis of invasive BC (established with core needle biopsy of the breast lesion)&#xD;
&#xD;
          -  Breast carcinoma measures &gt; 20 mm ultrasonographically&#xD;
&#xD;
          -  Pre-operative US+FNAC is negative or inconclusive&#xD;
&#xD;
          -  No evidence of distant metastases&#xD;
&#xD;
          -  ASA Classification I-III&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous breast surgery in the affected breast&#xD;
&#xD;
          -  History of previous axillary surgery in the ipsilateral axilla&#xD;
&#xD;
          -  History of radiation therapy (ipsilateral breast or axilla)&#xD;
&#xD;
          -  History of neo-adjuvant therapy (for the BC)&#xD;
&#xD;
          -  Known allergy to lidocain&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hermien Schreurs, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Center Alkmaar</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Martijn Leenders, MD</last_name>
    <phone>+31624271275</phone>
    <email>m.w.h.leenders@mca.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hermien Schreurs, MD, PhD</last_name>
    <phone>+31725484444</phone>
    <email>w.h.schreurs@mca.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical Center Alkmaar</name>
      <address>
        <city>Alkmaar</city>
        <state>Noord-Holland</state>
        <country>Netherlands</country>
      </address>
    </facility>
    <investigator>
      <last_name>Martijn Leenders, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hermien Schreurs, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne Roukema, MD, PhD, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shirley Go, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Henk-Jan Slooten van, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Metha Klaver, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tjeerd Ploeg, van der, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical Center Alkmaar</investigator_affiliation>
    <investigator_full_name>M.W.H. Leenders</investigator_full_name>
    <investigator_title>M.W.H. Leenders, M.D.</investigator_title>
  </responsible_party>
  <keyword>Sentinel Lymph Node Biopsy</keyword>
  <keyword>Local Anaesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02187718
org study id: NL49489.094.14
nct id: NCT02187718
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of operations under general anaesthesia
time frame: 6 months
measure: Number of operations under local anaesthesia
time frame: 6 months
measure: The number of patients in whom breast surgery is performed ≤21 days.
time frame: 6 months
measure: Quality of Life
time frame: 6 months
description: Quality of Life is measured with the WHOQOL-bref questionnaire
measure: Depressive symptoms
time frame: 6 months
description: Depressive symptoms are measured with the Centre for Epidemiological Studies-Depression scale (CES-D)
measure: Anxiety
time frame: 6 months
description: Anxiety is measured with the State-and-Trait-Anxiety-Inventory (STAI)
measure: Pain during SNP under local anaesthesia
time frame: 6 months
description: Pain during SNP under local anaesthesia is measured with a Numeric Pain Rating Scale
measure: Duration of SNP under local anaesthesia
time frame: 6 months
measure: Duration of SNP under general anaesthesia
time frame: 6 months
measure: Number of lymph nodes excised by SNP under local anaesthesia
time frame: 6 months
measure: Number of lymph nodes excised by SNP under general anaesthesia
time frame: 6 months
arm group label: SNPGA
arm group type: Other
description: Sentinel Node Procedure under General Anaesthesia
arm group label: SNPLA
arm group type: Other
description: Sentinel Node Procedure under Local Anaesthesia
intervention type: Procedure
intervention name: Sentinel Node Procedure under Local Anaesthesia
arm group label: SNPLA
intervention type: Procedure
intervention name: Sentinel Node Procedure under General Anaesthesia
arm group label: SNPGA
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hermien Schreurs, MD, PhD
role: Principal Investigator
affiliation: Medical Center Alkmaar
last name: Martijn Leenders, MD
phone: +31624271275
email: m.w.h.leenders@mca.nl
last name: Hermien Schreurs, MD, PhD
phone: +31725484444
email: w.h.schreurs@mca.nl
facility: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Medical Center Alkmaar
investigator full name: M.W.H. Leenders
investigator title: M.W.H. Leenders, M.D.
mesh term: Breast Neoplasms
mesh term: Anesthetics