Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06186011
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-12-15
Brief Title:
Quality of Life and Cosmetic Outcomes of Breast-Conserving Surgery According to Localization Method
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Quality of Life and Cosmetic Outcomes of Breast-Conserving Surgery According to Localization Method TRIGUIDE Trial - A Randomized Trial
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIGUIDE
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
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 tumors 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
METHODPROCEDURES
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 surgeons 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
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 tumors 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
METHODPROCEDURES
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 surgeons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None