Evaluation of the Feasibility of a Study Comparing Local Anesthesia and General Anesthesia in Conservative Surgery for Breast Cancer (ESCAL)

March 27, 2025 updated by: Centre Hospitalier Universitaire de Besancon

The conservative surgery for breast cancer is the first treatment for cancer and includes :

  • A partial mastectomy (removal of part of the breast)
  • A sentinel lymph node analysis, depending on the case (analysis of the first lymph node(s) draining the affected breast).

This is a common procedure in the gynecology operating room, usually performed under general anesthesia. However, with surgical advancements and less invasive procedures, it has become possible and common for patients to undergo surgery in our department under local anesthesia. No data in the medical literature has yet evaluated this new anesthetic approach.

Through this study, we aim to assess the feasibility and acceptability of partial mastectomy surgery with sentinel lymph node removal under either local anesthesia or general anesthesia.

The ultimate goal of this study is to allow future patients to benefit from faster outpatient surgery, requiring less hospital stay, and to continue the progress of minimizing surgical interventions that has already been successfully undertaken in breast cancer treatment.

This is an interventional study because it involves randomization, which determines for each enrolled patient whether they will receive general anesthesia or local anesthesia. It is a feasibility and acceptability study

It is important to note that the surgery itself will not differ between the two groups: only the method of anesthesia will change. This research is being conducted at the University Hospital of Besançon and only at this center.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Franche Comte
      • Besancon, Franche Comte, France, 25000
        • CHU de Besancon
        • Contact:
        • Sub-Investigator:
          • PIERRE BEDAT
        • Principal Investigator:
          • YOLANDE ESCOT-MAISONNETTE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female over 18 years of age
  • Diagnosis of invasive breast cancer (histological proof via breast biopsy)
  • Tumor size less than or equal to clinical T2 according to the current cTNM classification for breast cancer"
  • No clinical and/or radiological evidence of lymph node involvement
  • Affiliation to a French social security scheme or beneficiary of such a scheme
  • Approval in the multidisciplinary tumor board meeting for conservative treatment with partial mastectomy combined with sentinel lymph node biopsy
  • Signed informed consent indicating that the patient understands the purpose and procedures required by the study and agrees to participate in the study and comply with its requirements and restrictions

Exclusion Criteria:

  • Severe and morbid obesity (BMI strictly greater than 35)
  • Emaciation (BMI strictly less than 18.5)
  • Contraindication to the medications used in the protocol
  • Contraindication to general anesthesia
  • Contraindication to the local anesthesia protocol
  • Tumor considered non-resectable under local anesthesia according to the surgeon's assessment
  • Bifocal tumor
  • Associated oncoplastic procedure
  • Contralateral surgical procedure (implantable port placement, mastopexy, partial or total mastectomy)
  • Withdrawal of consent prior to surgery
  • Legal incapacity or limited legal capacity
  • Non-fluency in the French language or poor understanding as anticipated by the investigator
  • Subject without health insurance
  • Pregnant woman
  • Subject currently in the exclusion period of another study or listed in the national volunteer registry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With local anesthesia
local anesthesia
Procedure: conservative surgery for breast cancer with local anesthesia
conservative surgery for breast cancer with local anesthesia
Active Comparator: With general anesthesia
general anesthesia
Procedure: conservative surgery for breast cancer with general anesthesia
conservative surgery for breast cancer with general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Time Frame: 2 years
Recruitment capacity : number of women per month meeting the inclusion criteria
2 years
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Time Frame: 2 years
Acceptability : proportion of patients who accepted inclusion in the study among those to whom it was proposed
2 years
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Time Frame: 2 years
Adherence : proportion of women included in the study who do not withdraw their consent before the start of surgery
2 years
Evaluate the overall feasibility of a prospective randomized two-arm protocol: 'Local Anesthesia' and 'General Anesthesia' in the context of partial mastectomy combined with sentinel lymph node study.
Time Frame: 3 months
Completeness : proportion of questionnaires completed at each time point of the study
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the effectiveness and success of conservative surgery, including partial mastectomy combined with sentinel lymph node biopsy under non-tumescent local anesthesia without sedation in breast cancer
Time Frame: 3 months
Proportion of surgical procedures in which the entire operative procedure could be performed under local anesthesia without the need for general anesthesia.
3 months
Quantify postoperative pain in both arms of the study
Time Frame: 15 days
Numerical rating scale for pain assessment 2 hours after leaving the operating room, 24 hours after discharge from the hospital, and 15 days after the procedure. Numerical rating scale for pain assessment and DN2 score at 3 months post-procedure.
15 days
Quantify postoperative satisfaction and well-being in both arms of the study.
Time Frame: 3 months

BREAST-Q - Breast Conserving Therapy Module

Subscales of the BREAST-Q:

Scale 6: Physical well-being: breast (preoperative) Scale 7: Physical well-being: breast (postoperative)
3 months
Describe the oncological, anesthetic, and surgical safety of the surgical procedure in both arms of the study.
Time Frame: 3 months
Need for reoperation of the breast (margins considered positive in case of 'at ink' involvement [tumor in contact with the ink] for the infiltrative component and possibly associated in situ component) Need for reoperation of the axillary region Allergic reactions Other side effects related to general or local anesthesia Postoperative surgical complications (hematoma, abscess, wound dehiscence) Length of hospital stay Death
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/927

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on conservative surgery for breast cancer with local anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe