Prepectoral and Subpectoral Implant-based Breast Reconstruction
Primary Purpose
Breast Carcinoma, Breast Reconstruction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
prepectoral implant-based reconstruction
subpectoral implant-based reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Breast Carcinoma focused on measuring breast carcinoma, breast reconstruction, Prepectoral prosthetic breast reconstruction, Complication
Eligibility Criteria
Inclusion Criteria:
- More than 18 years old
- Female
- Preoperative pathology confirming invasive breast carcinoma or ductal carcinoma in situ
- Clinical T1 and T2 (Maximum tumor diameter ≤5 cm)
- Clinical ALN negative (Clinical physical examination and ultrasound indicate axillary lymph node negative; Suspected abnormality of axillary lymph node, and fine needle aspiration negative)
- No clinical or imaging evidence of distant metastasis
- Patients to receive skin sparing mastectomy or nipple sparing mastectomy
- BMI < 35
- Patients with no or mild mastoptosis
- Prosthesis to be implanted <500 ml
- Be able and willing to sign the Informed Consent Form (ICF)
Exclusion Criteria:
- Patients with the breast of moderate-severe mastoptosis, or requiring the use of Wise-pattern or other breast lift methods for subcutaneous mammary gland resection
- BMI>=35
- Patients who have received symmetrical breast surgery on the unaffected side immediately or later
- Patients with locally advanced breast cancer to receive neoadjuvant therapy
- Patients currently participating in other clinical trials, which may have impact on the participation in this trial
- Neoadjuvant therapy has been completed, and there is clear indication of adjuvant radiotherapy after the operation
- Previous history of breast cancer (patients with ipsilateral recurrence after breast sparing surgery)
- Pregnancy breast-feeding women
- History of smoking
- Previous history of diabetes
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prepectoral Group
Subpectoral Group
Arm Description
Prepectoral implant-based reconstruction applied for patients in this group
Subpectoral implant-based reconstruction applied for patients in this group
Outcomes
Primary Outcome Measures
Patients' satisfaction
Patients' satisfaction evaluated based on Breast-Q scale
Secondary Outcome Measures
Incidences of complications and serious complications
Incidences of complications and serious complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04688697
Brief Title
Prepectoral and Subpectoral Implant-based Breast Reconstruction
Official Title
A Multicentric, Open-labeled, Prospective, Randomized Controlled Study to Compare the Satisfaction and Safety of the Prepectoral and Subpectoral Implant-based Breast Reconstruction in Patients Receiving Immediate Breast Reconstruction Using Implant Combined With TiLoop® Bra After Skin Sparing or Nipple-areola Sparing Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Anticipated)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Breast cancer is one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of breast reconstruction increase year by year, while implant reconstruction has become the most important way of breast reconstruction due to its less injury, shorter time of operation and relatively simple surgical technique. In the long-term clinical practice, due to the lack of safe and effective alternative methods, the reconstruction method with prosthesis placed to posterior pectoralis major has been accepted by surgeons and patients, and has become the most commonly used method of prosthesis construction. However, the development of biomaterials provides new ideas for breast reconstruction. At present, more and more doctors in clinical practice discontinue the use of serratus anterior, but use the synthetic mesh (mostly titanium mesh TiLoop® Bra) or allogeneic acellular dermal matrix mesh to cover part of the dilator or prosthesis so as to shorten the entire operation cycle and make the appearance of the reconstructed breast more natural and aesthetic. In particular, it can improve the contour of the folds under the breast and shape the breasts with a certain degree of sagging.
This study takes the patients receiving immediate reconstruction with an implant combined with TiLoop® Bra after total mastectomy as the subjects, aiming to compare the aesthetics and safety of the placement of implant to anterior and posterior pectoralis major through a prospective and randomized study. The primary objective of the study is to analyze the aesthetics of breast appearance, patient satisfaction and postoperative quality of life (QOL) of the placement of implant to anterior and posterior pectoralis major. The secondary objective of the study is to analyze the incidence of complications and type of reoperation in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Breast Reconstruction
Keywords
breast carcinoma, breast reconstruction, Prepectoral prosthetic breast reconstruction, Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prepectoral Group
Arm Type
Experimental
Arm Description
Prepectoral implant-based reconstruction applied for patients in this group
Arm Title
Subpectoral Group
Arm Type
Active Comparator
Arm Description
Subpectoral implant-based reconstruction applied for patients in this group
Intervention Type
Procedure
Intervention Name(s)
prepectoral implant-based reconstruction
Intervention Description
In this group, patients receive breast reconstruction with prosthesis placed to anterior pectoralis major, synthetic mesh is used to enclose the prosthesis and place it to anterior pectoralis major.
Intervention Type
Procedure
Intervention Name(s)
subpectoral implant-based reconstruction
Intervention Description
In this group, patients receive breast reconstruction with placed to posterior pectoralis major, part of the mesh is placed under the pectoralis major during the operation, and the mesh is used to cover the suture of the prosthesis on the inferior plica, or to directly enclose the lower part of the implant.
Primary Outcome Measure Information:
Title
Patients' satisfaction
Description
Patients' satisfaction evaluated based on Breast-Q scale
Time Frame
18 months after the operation
Secondary Outcome Measure Information:
Title
Incidences of complications and serious complications
Description
Incidences of complications and serious complications
Time Frame
During 18 months after the operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
More than 18 years old
Female
Preoperative pathology confirming invasive breast carcinoma or ductal carcinoma in situ
Clinical T1 and T2 (Maximum tumor diameter ≤5 cm)
Clinical ALN negative (Clinical physical examination and ultrasound indicate axillary lymph node negative; Suspected abnormality of axillary lymph node, and fine needle aspiration negative)
No clinical or imaging evidence of distant metastasis
Patients to receive skin sparing mastectomy or nipple sparing mastectomy
BMI < 35
Patients with no or mild mastoptosis
Prosthesis to be implanted <500 ml
Be able and willing to sign the Informed Consent Form (ICF)
Exclusion Criteria:
Patients with the breast of moderate-severe mastoptosis, or requiring the use of Wise-pattern or other breast lift methods for subcutaneous mammary gland resection
BMI>=35
Patients who have received symmetrical breast surgery on the unaffected side immediately or later
Patients with locally advanced breast cancer to receive neoadjuvant therapy
Patients currently participating in other clinical trials, which may have impact on the participation in this trial
Neoadjuvant therapy has been completed, and there is clear indication of adjuvant radiotherapy after the operation
Previous history of breast cancer (patients with ipsilateral recurrence after breast sparing surgery)
Pregnancy breast-feeding women
History of smoking
Previous history of diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiajian Chen
Phone
+8618221810450
Email
elwin1020@163.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiajian Chen
Phone
+8618221810450
Email
elwin1020@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided
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Prepectoral and Subpectoral Implant-based Breast Reconstruction
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