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

NCT06910280 | Not Yet Recruiting

• 1 other identifier: 2024/927
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast cancer; conservative surgery; local anesthesia; quality of life

Outcome Measures

Primary Outcomes (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.

  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.

  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.

  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.

  Completeness : proportion of questionnaires completed at each time point of the study

  3 months

Secondary Outcomes (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

  3 months

• Quantify postoperative pain in both arms of the study

  15 days

• Quantify postoperative satisfaction and well-being in both arms of the study.

  3 months

• Describe the oncological, anesthetic, and surgical safety of the surgical procedure in both arms of the study.

  3 months

Study Arms (2)

With local anesthesia

EXPERIMENTAL

local anesthesia

Procedure: conservative surgery for breast cancer with local anesthesia

With general anesthesia

ACTIVE COMPARATOR

general anesthesia

Procedure: conservative surgery for breast cancer with general anesthesia

Interventions

conservative surgery for breast cancer with local anesthesia PROCEDURE

conservative surgery for breast cancer with local anesthesia

With local anesthesia

conservative surgery for breast cancer with general anesthesia PROCEDURE

conservative surgery for breast cancer with general anesthesia

With general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besancon

Besançon, Franche Comte, 25000, France

Location

Related Publications (23)

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Saint-Roch P. L'anesthésie locale tumescente a-t-elle une place ? 2013;

  BACKGROUND

• 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;

  BACKGROUND

• 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 BACKGROUND

• Ceccarino R, Di Micco R, Cappelletti R. Aesthetic Breast Surgery Under Cold Tumescent Anesthesia: Feasibility and Safety in Outpatient Clinic. Ann Plast Surg. 2019 Oct;83(4):384-387. doi: 10.1097/SAP.0000000000001798.

  PMID: 31524728 BACKGROUND

• Boeer B, Helms G, Pasternak J, Roehm C, Kofler L, Haefner HM, Moehrle M, Heim E, Fischer H, Brucker SY, Hahn M. Back to the future: breast surgery with tumescent local anesthesia (TLA)? Arch Gynecol Obstet. 2023 Sep;308(3):935-940. doi: 10.1007/s00404-023-06938-5. Epub 2023 Mar 6.

  PMID: 36872392 BACKGROUND

• Groetelaers RP, van Berlo CL, Nijhuis PH, Schapers RF, Gerritsen HA. Axillary recurrences after negative sentinel lymph node biopsy under local anaesthesia for breast cancer: a follow-up study after 5 years. Eur J Surg Oncol. 2009 Feb;35(2):159-63. doi: 10.1016/j.ejso.2008.07.017. Epub 2008 Sep 11.

  PMID: 18789841 BACKGROUND

• van Berlo CL, Hess DA, Nijhuis PA, Leys E, Gerritsen HA, Schapers RF. Ambulatory sentinel node biopsy under local anaesthesia for patients with early breast cancer. Eur J Surg Oncol. 2003 May;29(4):383-5. doi: 10.1053/ejso.2002.1420.

  PMID: 12711294 BACKGROUND

• Luini A, Gatti G, Frasson A, Naninato P, Magalotti C, Arnone P, Viale G, Pruneri G, Galimberti V, De Cicco C, Veronesi U. Sentinel lymph node biopsy performed with local anesthesia in patients with early-stage breast carcinoma. Arch Surg. 2002 Oct;137(10):1157-60. doi: 10.1001/archsurg.137.10.1157.

  PMID: 12361425 BACKGROUND

• Luini A, Caldarella P, Gatti G, Veronesi P, Vento AR, Naninato P, Arnone P, Sangalli C, Brenelli F, Sosnovskikh I, Peradze N, Dussan Luberth CA, Viale G, Paganelli G. The sentinel node biopsy under local anesthesia in breast cancer: advantages and problems, how the technique influenced the activity of a breast surgery department; update from the European Institute of Oncology with more than 1000 cases. Breast. 2007 Oct;16(5):527-32. doi: 10.1016/j.breast.2007.04.003.

  PMID: 17916496 BACKGROUND

• Luini A, Gatti G, Zurrida S, Galimberti V, Paganelli G, Naninato P, Caldarella P, Rotmensz N, Winnikow E, Viale G. The sentinel lymph node biopsy under local anesthesia in breast carcinoma: experience of the European Institute of Oncology and impact on quality of life. Breast Cancer Res Treat. 2005 Jan;89(1):69-74. doi: 10.1007/s10549-004-1473-y.

  PMID: 15666199 BACKGROUND

• Kongdan Y, Chirappapha P, Lertsithichai P. Effectiveness and reliability of sentinel lymph node biopsy under local anesthesia for breast cancer. Breast. 2008 Oct;17(5):528-31. doi: 10.1016/j.breast.2008.04.003. Epub 2008 Jun 2.

  PMID: 18515105 BACKGROUND

• Gauthier T, Garuchet-Bigot A, Mollard J, Aubard Y. [How I... remove axillary sentinel lymph node under local anesthesia]. Gynecol Obstet Fertil. 2010 Jun;38(6):418-9. doi: 10.1016/j.gyobfe.2010.04.004. Epub 2010 Jun 4. No abstract available. French.

  PMID: 20576555 BACKGROUND

• Fenaroli P, Tondini C, Motta T, Virotta G, Personeni A. Axillary sentinel node biopsy under local anaesthesia in early breast cancer. Ann Oncol. 2000 Dec;11(12):1617-8. doi: 10.1093/oxfordjournals.annonc.a010407. No abstract available.

  PMID: 11205475 BACKGROUND

• Institut national du cancer. Traitements locorégionaux des cancers du sein infiltrants non métastatiques / Synthèse, collection Recomman- dations et référentiels. 2022.

  BACKGROUND

• HAS. Haute Autorité de Santé. Infracyanine (vert d'indocyanine monopic) - Repérage peropératoire du ganglion sentinelle. 2022.

  BACKGROUND

• Lucas N, Interne SB, Laine P, Nicolie B, Fondrinier E. [Anaphylactic shock due to patent blue: four case report and review of literature]. J Gynecol Obstet Biol Reprod (Paris). 2010 Apr;39(2):116-20. doi: 10.1016/j.jgyn.2009.10.006. Epub 2010 Jan 15. French.

  PMID: 20079974 BACKGROUND

• C. Ngô, C. Nos, A.-S. Bats, C. Bensaid, F. Lécuru. Chirurgie locorégional des cancers du sein. In: Encyclopédie Médico-chirurgicale. Elsevier-Masson. 2020.

  BACKGROUND

• Modi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):610-621. doi: 10.1056/NEJMoa1914510. Epub 2019 Dec 11.

  PMID: 31825192 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anesthesia, Local; Anesthesia, General

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: April 4, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-01

Locations

FR (1)