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临床试验/NCT00473122
NCT00473122已完成2 期

Delayed-Immediate Breast Reconstruction

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
200
试验地点
2
主要终点
Efficacy of Delayed-Immediate Breast Reconstruction

研究概览

简要总结

The goal of this clinical research study is to evaluate a new two-stage approach (delayed-immediate reconstruction) to breast reconstruction in women who may require post-mastectomy radiation therapy. Researchers will compare the cosmetic outcomes and any complications that occur in women who receive delayed-immediate reconstruction to those who receive the standard approaches (either immediate reconstruction or delayed breast reconstruction).

详细描述

In women who have a mastectomy and desire breast reconstruction, the best timing of breast reconstruction depends on whether radiation therapy (XRT) is needed. If XRT is not needed, immediate reconstruction offers the best cosmetic result. However, if XRT is needed, it is better to delay reconstruction until XRT is complete. There are 2 reasons to wait. First, the presence of a reconstructed breast can interfere with the delivery of XRT, decreasing the effectiveness of this treatment. Second, exposing a reconstructed breast to radiation can cause poor cosmetic results. Today, many women are not offered immediate reconstruction because it is not known at the time of their mastectomy whether they will need XRT. Researchers believe that for such women, a new approach called "delayed-immediate reconstruction" will offer the cosmetic benefits of immediate reconstruction without the potential drawbacks of ineffective treatment.

If you agree to take part in this study, you will have your already scheduled skin-sparing mastectomy. However, at the time of your routine mastectomy, you will also have a tissue expander or postoperatively adjustable implant (fully inflated with saline or as allowed by the remaining capacity [space] of the retained breast skin) placed in your breast. Some patients will have a small biopsy of skin, that is normally discarded, done so that scientists can learn about changes and ways of healing after radiation. When the final pathology report is complete (about 1 week after mastectomy), the radiation doctor and/or your surgeon will decide whether or not you need XRT.

If the results show that you do not need XRT, you will have the tissue expander or implant removed and will have standard definitive breast reconstruction, using the preserved breast skin about 2 weeks after mastectomy. The reconstructive technique used will be decided based on anatomical considerations, surgical factors, and your personal desires. The postoperative follow-up will be similar to that of patients who have standard immediate breast reconstruction.

If the results show that you do need XRT, the tissue expander or adjustable implant will be completely deflated in the plastic surgery clinic before you receive standard XRT. Radiation must be given either at MD Anderson or an MD Anderson-affiliated site. Deflation of the tissue expander or implant will result in a flat chest wall that will decrease difficulties with radiation delivery that can occur after an immediate breast reconstruction. If you also require chemotherapy after mastectomy, the tissue expander or implant will remain inflated during chemotherapy (additional saline-filling may also be performed during chemotherapy, if required). In patients who have already received chemotherapy before mastectomy or who will not require chemotherapy, the expander or implant will remain inflated during the 4-to-6-week period between mastectomy and XRT. About 3 weeks into your radiation treatments, you will come in to the plastic surgery clinic for a follow-up to check on the status of the implants.

Several weeks after the completion of XRT, the tissue expander or postoperatively adjustable implant will be gradually re-expanded over about 6-months. The internal scar capsule that forms around the tissue expander or implant before deflation usually allows for re-expansion after radiation therapy. Re-expansion after radiation therapy will be performed during postoperative visits to the plastic surgery clinic every 2-to-4 weeks until the desired size is achieved. About 6 months after the completion of XRT, a "skin-preserving" delayed reconstruction with a preference for autologous tissues only (no breast implants) will be performed. This will involve removal of the tissue expander or implant and definitive breast reconstruction. At the time of the skin-preserving delayed reconstruction, a small biopsy of usually thrown away radiated breast tissue as well as a sample of the skin, that is normally discarded, of the flap (your tissue that is taken from your back, stomach or buttock to build the breast) and a sample of the implant or tissue expander will be collected for laboratory evaluation. Researchers will evaluate the skin changes from radiation and expansion as well as from the internal scar capsule. This will be compared to radiated skin biopsies without expansion and biopsies taken after skin expansion without radiation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients with clinical stage I or stage II breast cancer who may require postmastectomy XRT.
  • Patients will be required to receive postmastectomy XRT as well as breast reconstructive procedures, including subsequent deflation and re-inflation of the prosthesis after XRT at University of Texas MD Anderson Cancer Center (UT MDACC).
  • Patients must sign the consent form and must be able to withstand two (2) anesthetic procedures.
  • Patients with stage I breast cancer who will be eligible for delayed-immediate breast reconstruction will have extensive microcalcifications within the affected by mammography that make it difficult to determine preoperatively the extent of invasive disease.

排除标准

  • Patients with stage III or stage IV breast cancer who are known preoperatively to require postmastectomy XRT.
  • Patients with stage I breast cancer who are unlikely to require postmastectomy XRT.

结局指标

主要结局

Efficacy of Delayed-Immediate Breast Reconstruction

时间窗: 5 Years

Patient data and photographs gathered throughout the various stages of delayed-immediate reconstruction, during routine preoperative, intraoperative, and postoperative examinations. Details of primary disease include preoperative tumor stage, method of breast cancer diagnosis, tumor biologic characteristics, and the use of neoadjuvant chemotherapy. Preoperative and postoperative tumor stage compared to evaluate the indications for the delayed-immediate approach to breast reconstruction.

次要结局

  • Compare Aesthetic Outcomes for Immediate-Delayed Breast Reconstruction(5 Years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Delayed-Immediate Breast Reconstruction | 临床试验