A Prospective, Multicenter, Controlled Clinical Study of 3D-printed Biodegradable Breast Implants for Breast Restoration
- Conditions
- Breast CancerBreast Reconstruction
- Registration Number
- NCT06993714
- Lead Sponsor
- Xijing Hospital
- Brief Summary
The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as controls. It will also explore the safety of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction. The main question it aims to answer is:
Can breast cancer patients who are not suitable for breast-conserving surgery use 3D-printed biodegradable material breast implants for breast reconstruction? Do patients who undergo breast reconstruction based on 3D-printed biodegradable material breast implants have advantages over those who receive breast-conserving surgery or traditional silicone prosthesis breast reconstruction surgery in terms of cosmetic effects, quality of life and safety? What medical problems may occur when participants use 3D-printed biodegradable material-based breast implants for breast reconstruction?
Participants will:
Non-random enrollment. In the experimental group, breast reduction surgery based on 3D-printed degradable biological implants was received; In control group 1, traditional breast-conserving surgery was received; Traditional silicone prosthesis breast reconstruction was received in control Group 2.
- Detailed Description
This study was a prospective, multicenter, controlled clinical study and was divided into three groups. The experimental group received breast reconstruction with 3D-printed biodegradable material breast implants, while the control group received traditional breast-conserving surgery or breast reconstruction with silicone prostheses.
1. Inclusion criteria Female patients with newly diagnosed primary breast cancer aged 18 to 70 years and confirmed by histopathology 2) Willing to undergo breast-conserving or concurrent silicone prosthesis breast reconstruction or 3D-printed biodegradable material breast implant breast reconstruction 3) It has indications for subcutaneous glandectomy that preserves the nipples and areolas 4) ECOG physical fitness score: 0-1 point; 5) If neoadjuvant chemotherapy is received, the time interval between the end of chemotherapy and surgery should be less than 8 weeks; 6) The patient has good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent form;
2. Exclusion criteria Age \>70 years old; 2) Newly diagnosed stage IV metastatic breast cancer; 3) Multicentric, extensive, diffuse lesions or inflammatory breast cancer; 4) The tumor invades the papillary areola complex; 5) Cannot accept/tolerate radiotherapy; 6) Breast cancer during pregnancy 7) Other malignant tumors have occurred within the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer.
8) Abnormal functions of vital organs such as the heart, lungs, liver and kidneys, poorly controlled diabetes, etc., which cannot tolerate surgery; 9) Patients who were judged by the researchers as unsuitable to participate in this study.
3. Elimination criteria
If the subjects have the following situations, they must be excluded from the study:
1. Did not receive the established surgical plan after enrollment;
2. A large amount of research data is missing;
3. Those that seriously violate the plan and are judged by the researcher to be necessary to be excluded.
4. Termination of research criteria
The subjects may terminate the study for any of the following reasons:
1. If the patient is unwilling to continue participating in the trial study, no reason needs to be provided.
2. The researchers believe that continuing to participate in the study is not conducive to the treatment of patients.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postoperative cosmetic effects and quality of life One year after the operation The patient satisfaction in the reconstruction module of the BREAST-Q scale was used for scoring, including: satisfaction with the Breast, satisfaction with the surgical outcome, and satisfaction with the treatment. Among them, the breast satisfaction score was the main endpoint of this study After the BREAST-Q questionnaire is completed, its score will be calculated and it is called Q-SCORE. The specific assessment requires the aid of the Q-SCORE scoring software. The surgical satisfaction score, treatment satisfaction score and health-related quality of life (QOL) score in the Breast-Q scale include: physical, psychosocial and sexual health. For all dimensions, the higher the score reported by patients, the higher their satisfaction and the better their quality of life.
- Secondary Outcome Measures
Name Time Method Recurrence-free survival (RFS) Three months, half a year, one year after the operation, and then once a year thereafter until ten years Imaging examinations confirm recurrence at the ipsilateral breast, ipsilateral chest wall or skin, and surgical scar sites. The date of the earliest discovered imaging examination is defined as the "local recurrence date".
When local recurrence is diagnosed through clinical history and physical examination findings, the date of clinical "local recurrence" is determined as the "local recurrence day".
In cases where local recurrence is diagnosed through cytology or tissue biopsy pathology, the earliest date of cytology or tissue biopsy pathology examination shall be regarded as the "local recurrence date".
The time starting from the day of the surgery and ending from the date of disease recurrence/death. In the case where neither death nor tumor recurrence was observed through follow-up, the final date for confirming no recurrence was reached.
Only an increase in relevant tumor markers such as CEA cannot be diagnosed as recurrence.Disease-free survival (DFS) Three months, half a year, one year after the operation, and then once a year thereafter until ten years The time starting from the day of the surgery and ending from the date of tumor recurrence (if the specific date of tumor recurrence is unknown, the date of death due to the tumor is taken as the ending point). In the case where neither death nor tumor recurrence is followed up and observed, the final date for confirming no recurrence (the final recurrence-free survival confirmation date: the last date among the outpatient visit date or the examination date) is used up.
Overall survival (OS) Three months, half a year, one year after the operation, and then once a year thereafter until ten years The time between taking the day of the surgery as the starting point and deaths caused by various reasons as the ending point (when no death occurs, the time of the last follow-up is the ending point). In the case of survival, until the final date of survival confirmation. In cases where follow-up and tracking are not possible, the period ends on the last date when survival is confirmed before follow-up and tracking cannot be conducted.
Surgical technique safety (incidence of complications) Immediately after the operation, and at 3 days, 7 days, 10 days, 14 days, 1 month, 3 months, 6 months, 12 months and 24 months after the operation Intraoperative complications encompass, but are not restricted to, intraoperative bleeding, vital blood vessel injury, subcutaneous emphysema, etc. Their incidence is calculated by using the total number of patients undergoing surgical treatment as the denominator and the number of patients experiencing any intraoperative complication as the numerator.
Postoperative complications include, but are not limited to, infection, flap or nipple-areola necrosis, abnormal sensation in the surgical site, and prosthesis-related complications. Similarly, the calculation of their occurrence rate involves taking the total number of surgically treated patients as the denominator and the number of patients with any postoperative complication as the numerator.
Regarding the rate of unplanned secondary surgeries, it is determined by using the total number of patients who received surgical treatment as the denominator and the number of patients undergoing unplanned secondary surgeries as the numerator.
Trial Locations
- Locations (1)
Xijing hospital
🇨🇳Xi'an, Shaanxi, China