Quality of Life and Cosmetic Outcomes of Breast-Conserving Surgery According to Localization Method

Breast Cancer Clinical Trial

— TRIGUIDE  

Official title:

Quality of Life and Cosmetic Outcomes of Breast-Conserving Surgery According to Localization Method (TRIGUIDE Trial) - A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06186011
• Other study ID #: HCB/2023/0141
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: Hospital Clinic of Barcelona
• Contact: Eduard Mension, MD PhD
• Phone: +34 626207171
• Email: edmension[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Wire-guided surgery
If assigned to the WGS, the marking will be performed by the radiologist on the day prior to the intervention.
• Radioactive seed localization
If assigned to the RSL, the marking will be performed by the radiologist on the day prior to the intervention. The handling and traceability will be done by the nuclear medicine physician.
• Intraoperative ultrasound localization
If the patient is assigned to the Intraoperative ultrasound localization (IOUS), no further procedures will be necessary until surgery. Subsenquently, the primary surgery will be performed.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCCT.core	BCCT.core is a semi-automatic software validated for the assessment of cosmetic outcomes following BCS. It provides an objective measure and has been demonstrated to correlate well to a panel of experts. BCCT.core analyses several parameters including symmetry, skin colour and scar visibility to evaluate breast cosmesis, and classifies the overall cosmetic result into four classes: Excellent, Good, Fair and Poor. However, BCCT.core does not incorporate patient self-perception of outcome and does not directly assess the volume of breast excised. Standardized clinical photographs were taken 1-year post-surgery with or without radiotherapy, as recommended by the BCCT.core software developers and assessed at the end of the data collection period by a single investigator, blinded to the identification and treatment group of the participant.	12 months after surgery
Primary	BREAST-Q questionnaire	The BREAST-Q questionnaire is a specific and validated Patient-Reported Outcome Measure (PROM) for patients undergoing breast surgery designed to assess the outcomes and satisfaction of individuals, which measures health-related QoL (physical well-being, psychological and sexual) and satisfaction (satisfaction with the breast, satisfaction with the overall result and satisfaction with the care received). Each scale is scored to generate a numeric score on a scale from 0 (worst) to 100 (best). These measures were studied at baseline (preoperative) and 12 months post-surgery.	preoperative, 12 months after surgery
Secondary	Excess volume resection	Defined by the resected breast volume minus the tumor volume	Inmediatly after surgery
Secondary	Margin status	negative - no tumour cells at inked margin; or positive - tumour at the inked edge	Inmediatly after surgery
Secondary	Ampliations	Number of ampliations to reach negative margin status	Inmediatly after surgery
Secondary	Additional treatment interventions	Record the need for new surgeries, both for margin ampliation and complications	3 weeks and 12 months after surgery
Secondary	Excision time	defined in min as the time from the first mammary incision to wound closure	Inmediatly after surgery
Secondary	Postoperative complications	Seroma, hematoma, infection and their management (conservative, drainage, antibiotic therapy, drainage)	Inmediatly after surgery, 3 weeks and 12 months after surgery
Secondary	Surgeon satisfaction	Surgeon satisfaction with localization method with a Likert scale: - Very dissatisfied; - Dissatisfied; - Unsure; - Satisfied; - Very satisfied	Inmediatly after surgery