Clinical trial NCT06186011: Quality of Life and Cosmetic Outcomes of Breast-Conserving Surgery According to Localization Method
Official title: Quality of Life and Cosmetic Outcomes of Breast-Conserving Surgery According to Localization Method (TRIGUIDE Trial) - A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Quality of Life
Cosmetic outcomes
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center parallel randomized Clinical Trial with three arms: intraoperative Ultrasound vs. wire vs. radioactive seed
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare Quality of Life and cosmetic outcomes in Breast Conservative Carcer surgery depending on localization method (intraoperative Ultrasound, wire and radioactive seed).

Participants will be randomly assigned to one of the three proposed arms, and the primary surgery will be performed.

Detailed description: INTRODUCTION:

The surgery for breast cancer is increasingly emphasizing cosmetic outcomes, body image, and the quality of life (QoL) of patients. Survival is the top priority; however, other concerns or problem areas may arise, such as dissatisfaction with body image. All of this has implications for QoL, self-esteem, relationships, and sexual functionality. One of the challenges of breast conservative surgery (BCS) is suboptimal cosmetic results, which can be observed in up to 40% of patients in some series. Factors influencing the cosmetic outcome include patient characteristics such as weight or breast density, the volume of the tumor removed, the tumor's location in the breast, wound complications, and the dose and schedule of radiotherapy. Therefore, the use of low-visibility incisions, precise tumor resection, and the introduction of oncoplastic techniques have revolutionized the surgical management of these patients.

The localization of the lesion is a key point for surgical resection. Advancements in imaging diagnostic methods and molecular classification have led to a reevaluation of surgical approaches. The widespread use of mammography as a screening method for breast cancer has resulted in an increase in the detection of non-palpable breast lesions, necessitating the search for tools to detect these lesions. The intent of surgery should always be both radical and effective, meaning achieving the removal of the loco-regional disease. The main challenge in breast surgery lies in striking a balance between wide excision with clear margins and a satisfactory cosmetic outcome Currently, there are multiple localization techniques available, although the evidence from comparative studies is limited. Wire guided localization (WGL) is considered the standard method for intraoperative localization of non-palpable breast lesions and is the method of choice for many centers worldwide. However, alternative localization techniques such as radioguided occult lesion localization using radioactive iodine-125 seeds (RSL) and ultrasound guided surgery (UGS) have recently been shown to reduced re-excision rates. In a systematic review comparing different localization methods, UGS reduced the percentage of involved margins and significantly decreased the reoperation rate and surgical time when compared to WGL. UGS also showed a statistically significant reduction in the number of involved margins compared to RSL. All techniques were equivalent in terms of effectiveness, localization complications, and general complications. The available evidence on cosmetic outcomes and QoL in BCS according to the localization technique is limited.

We hypothesized UGS and RSL would be associated with a better QoL and cosmetic outcome compared to WGL. The aim of TRIGUIDE study was to compare the QoL and cosmetic outcomes of women who underwent BCS according the localization method.

METHOD/PROCEDURES:

All eligible patients scheduled for primary surgery with ecovisible lesions will be prospectively recruited from external Gynecology consultations. They will have attended the consultation according to the usual care pathway, after completing complementary tests and receiving a confirmed diagnosis. An ultrasound will be performed by the surgeon in the consultation to confirm the identification of the lesion. Baseline quality of life (QoL) will be assessed using the BREAST-Q questionnaire (preoperative).

The surgical procedure will be jointly decided by the surgeon and the patient and will not be modified by the study. Patients will be consecutively and randomly assigned to one of the three proposed arms. If the patient is assigned to the intraoperative ultrasound arm, no further procedures will be necessary until the surgery. If assigned to the wire or seed arm, the marking will be performed by the radiologist on the day prior to the intervention. The handling and traceability of the radioactive seed, if applicable, will be done by the nuclear medicine physician. Subsequently, the primary surgery will be performed. We will preserve the orientation of the specimen with marking sutures, such that positive resection margins could be identified and re-excised if necessary. Radiological margin assessment will be conducted during procedure and ampliations will be performed with the advice of the radiologist and the surgeon's discretion. We will undertake axillary surgery in the same session, according to international guideline. The surgical specimen will be postoperative processed and analyzed by the Pathology Department. A multi- disciplinary team will review all cases preoperatively and postoperatively, and we will administer adjuvant radio- therapy or systemic therapy according to institutional and national guidelines. Regular follow-up will be carried out by the Gynecology team, with a visit at 3-4 weeks and 12 months post-surgery.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with non-palpable and ecovisible infiltrating breast carcinoma, classified as T1 and T2, eligible for primary breast-conserving surgery (BCS)

Exclusion Criteria:

* lesions \<5mm
* multicentric tumors
* extensive calcifications not visible by ultrasound
* level III oncoplastic techniques or mastectomy

Primary outcomes:
measure: BCCT.core
timeFrame: 12 months after surgery
measure: BREAST-Q questionnaire
timeFrame: preoperative, 12 months after surgery
Secondary outcomes:
measure: Excess volume resection
timeFrame: Inmediatly after surgery
measure: Margin status
timeFrame: Inmediatly after surgery
measure: Ampliations
timeFrame: Inmediatly after surgery
measure: Additional treatment interventions
timeFrame: 3 weeks and 12 months after surgery
measure: Excision time
timeFrame: Inmediatly after surgery
measure: Postoperative complications
timeFrame: Inmediatly after surgery, 3 weeks and 12 months after surgery
measure: Surgeon satisfaction
timeFrame: Inmediatly after surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Eduard Mension, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: