Capsular Contracture After PMRT Using Prepectoral Versus Subpectoral Implant-based Breast Reconstruction: PREPER Trial

NCT ID: NCT04391296

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2025-06-30

Brief Summary

The purpose of this study is to prospectively compare and analyze the incidence of complications in patients undergoing postmastectomy radiation therapy after breast reconstruction with subpectoral and prepectoral placement of implant. Investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in lower risk of capsular contracture after postmastectomy radiation therapy(PMRT) compared with acellular dermal matrix(ADM)-assisted implant-based breast reconstruction with subpectoral implant placement.

Detailed Description

OUTLINE: This is a single center randomized clinical trial. Participant recruitment and enrollment will occur at Gangnam Severance Hospital Breast Cancer Center for 4 years, followed by one year of follow up data collection and analysis.

Arm I (Prepectoral): immediate ADM-assisted implant-based breast reconstruction with prepectoral implant placement.

Arm II (Subpectoral): immediate ADM-assisted implant-based breast reconstruction with subpectoral implant placement.

This clinical study is aimed at patients who have been diagnosed with breast cancer and who have undergone a total mastectomy for the therapeutic indication, and who are planning to undergo implant based reconstruction and postmastectomy radiotherapy.

It will be carried out prospectively in a single institution, and the study will be divided into two groups, subpectoral implant and prepectoral implant, according to the reconstruction method.

A total of 96 patients or 48 patients per arm will be recruited. Randomization will be accomplished using randomly permuted blocks, and randomization will be stratified on the basis of reconstruction method. (tissue expander insertion or direct-to-implant)

After completion of study treatment, patients are followed for 1 year for observation of capsular contracture and patient reported outcomes.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I (Prepectoral)

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.

Group Type: EXPERIMENTAL

Arm I (Prepectoral), Arm II (Subpectoral)

Intervention Type: PROCEDURE

Arm I (Prepectoral)De-epithelialized skin flaps are made from the inferior pole of breast skin and soft tissue. The implant pocket is shaped by fixing a sufficiently large amount of ADM to the medial surface of the mastectomy pocket, the upper edge of the pectoralis major muscle and the de-epithelial skin flap. The implant is located in the prepectoral mastectomy pocket and the ADM anchored to the chest wall, serratus fascia, and de-epithelial skin flaps. The pectoralis major muscle is located in the anatomical location behind the ADM.

Arm II (Subpectoral)The pectoralis major muscle is dissected from the thorax to create sufficient space for the implant to be placed behind the pectoralis major muscle. Implant pockets are made by suturing the lower part of the elevated pectoralis major muscle to the top of the de-epithelial skin flap and the ADM patch to the skin flap, the pectoralis major muscle, and the lateral thoracic fascia.

II (Subpectoral)

Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement.

Group Type: ACTIVE_COMPARATOR

Arm I (Prepectoral), Arm II (Subpectoral)

Intervention Type: PROCEDURE

Arm I (Prepectoral)De-epithelialized skin flaps are made from the inferior pole of breast skin and soft tissue. The implant pocket is shaped by fixing a sufficiently large amount of ADM to the medial surface of the mastectomy pocket, the upper edge of the pectoralis major muscle and the de-epithelial skin flap. The implant is located in the prepectoral mastectomy pocket and the ADM anchored to the chest wall, serratus fascia, and de-epithelial skin flaps. The pectoralis major muscle is located in the anatomical location behind the ADM.

Arm II (Subpectoral)The pectoralis major muscle is dissected from the thorax to create sufficient space for the implant to be placed behind the pectoralis major muscle. Implant pockets are made by suturing the lower part of the elevated pectoralis major muscle to the top of the de-epithelial skin flap and the ADM patch to the skin flap, the pectoralis major muscle, and the lateral thoracic fascia.

Interventions

Arm I (Prepectoral), Arm II (Subpectoral)

Arm I (Prepectoral)De-epithelialized skin flaps are made from the inferior pole of breast skin and soft tissue. The implant pocket is shaped by fixing a sufficiently large amount of ADM to the medial surface of the mastectomy pocket, the upper edge of the pectoralis major muscle and the de-epithelial skin flap. The implant is located in the prepectoral mastectomy pocket and the ADM anchored to the chest wall, serratus fascia, and de-epithelial skin flaps. The pectoralis major muscle is located in the anatomical location behind the ADM.

Arm II (Subpectoral)The pectoralis major muscle is dissected from the thorax to create sufficient space for the implant to be placed behind the pectoralis major muscle. Implant pockets are made by suturing the lower part of the elevated pectoralis major muscle to the top of the de-epithelial skin flap and the ADM patch to the skin flap, the pectoralis major muscle, and the lateral thoracic fascia.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age over 19 years old

2. Histologically confirmed diagnosis of unilateral breast cancer

3. Mastectomy (nipple or skin sparing mastectomy) candidate for therapeutic indication

4. Patient undergoing immediate implant based breast reconstruction

Exclusion Criteria

1. Underlying medical condition: for example, (AST or ALT >100U/L, inadequate renal function; eGFR < 30ml/min, congestive heart failure; New York Heart Association III-IV)

2. Prior history of radiotherapy on the affected side of breast or chest wall before mastectomy

3. History of a known additional malignancy Note: Participants with melanoma of skin, low grade thyroid cancer are not excluded.

4. Not able to provide informed consent (Illiterate, foreigners, etc.)

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joon Jeong

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2019-0837-002

Identifier Type: -

Identifier Source: org_study_id