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NCT Number: NCT06910280

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besancon

Besançon, Franche Comte, 25000, France

Location contact

PIERRE BEDAT

CONTACT

[email protected]

+330381218113

PIERRE BEDAT

SUB_INVESTIGATOR

YOLANDE ESCOT-MAISONNETTE

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conservative surgery for breast cancer with local anesthesia

Procedure

conservative surgery for breast cancer with local anesthesia

conservative surgery for breast cancer with general anesthesia

Procedure

conservative surgery for breast cancer with general anesthesia

Primary outcomes

  1. 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. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: ESCAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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