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

Обзор

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.

Вмешательства

• Процедура conservative surgery for breast cancer with local anesthesia
  conservative surgery for breast cancer with local anesthesia
• Процедура conservative surgery for breast cancer with general anesthesia
  conservative surgery for breast cancer with general anesthesia

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 3 months]

Вторичные конечные точки (4)

• 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 [Срок оценки: 3 months]
• Quantify postoperative pain in both arms of the study [Срок оценки: 15 days]
• Quantify postoperative satisfaction and well-being in both arms of the study. [Срок оценки: 3 months]
• Describe the oncological, anesthetic, and surgical safety of the surgical procedure in both arms of the study. [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 1 центр

• CHU de Besancon — Besançon

Публикации

• Seror J, Hequet D, Gout-Duracher C, Cittanova M laure. Faisabilité et impact de la chirurgie mammaire conservatrice sous anesthésie locale. Communication orale, Congrè SFSPM; 2022.
• Karanlik H, Kilic B, Yildirim I, Bademler S, Ozgur I, Ilhan B, Onder S. Breast-Conserving Surgery Under Local Anesthesia in Elderly Patients with Severe Cardiorespiratory Comorbidities: A Hospital-Based Case-Control Study. Breast Care (Basel). 2017 Mar;12(1):29-33. doi: 10.1159/000455003. Epub 2017 Feb 8. PMID 28611538
• Hirokawa T, Kinoshita T, Nagao T, Hojo T. A clinical trial of curative surgery under local anesthesia for early breast cancer. Breast J. 2012 Mar-Apr;18(2):195-7. doi: 10.1111/j.1524-4741.2011.01221.x. Epub 2012 Feb 2. No abstract available. PMID 22300192
• Carlson GW. Total mastectomy under local anesthesia: the tumescent technique. Breast J. 2005 Mar-Apr;11(2):100-2. doi: 10.1111/j.1075-122X.2005.21536.x. PMID 15730454
• Sleth JC, Lavie M, Mion P, Saizy C, Servais R. [Tumescent local anaesthesia for mastectomy: lidocaine plasma concentration]. Ann Fr Anesth Reanim. 2006 Jan;25(1):74-6. doi: 10.1016/j.annfar.2005.07.074. Epub 2005 Oct 26. No abstract available. French. PMID 16256296
• Saint-Roch P. L'anesthésie locale tumescente a-t-elle une place ? 2013;
• Anne-Pauline Cungi. Étude Hypno-Séno : anesthésie générale versus hypno-tumescence en chirurgie mammaire conservatrice : évaluation de la qualité des marges de résection chirurgicale. 2020;
• Sleth JC, Servais R, Saizy C. [Tumescent infiltrative anaesthesia for mastectomy: about six cases]. Ann Fr Anesth Reanim. 2008 Nov;27(11):941-4. doi: 10.1016/j.annfar.2008.08.011. Epub 2008 Nov 11. French. PMID 19004607

Идентификаторы

NCT: NCT06910280 · 2024/927

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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