Non-contrast Magnetic Resonance Angiography Efficacy and Safety Assessment for Perforators Mapping in Deep Inferior Epigastric Perforator Flap Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- The concordance ratio.
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of contrast-free magnetic resonance angiography (MRA) for deep inferior epigastric perforator flap planning. The investigators propose to perform a non-contrast MRA to achieve the following extremely important objectives: to avoid radiation exposure, minimize the risk of potentially harmful effects of contrast agents, and reduce the cost of the study.The investigators assume that the use of non-contrast MRA following our protocol including certain patient's positioning, a special pulse scanning sequence and perforators' projection method is effective and allows mapping of perforators without injecting a potential harmful contrast agent.
详细描述
Rationale. Contrast-free MRA is a new concept for preoperative planning in breast reconstruction that combines the advantages of magnetic resonance imaging (no ionising radiation exposure), requires no potentially harmful contrast agent, and at the same time is highly accurate.
Aim. The aim of the study is to evaluate the efficacy and safety of the contrast-free magnetic resonance angiography (MRA) for perforators mapping in deep inferior epigastric perforator flap planning.
Study design. A retro- and prospective non-randomised non-blinded cohort multicenter study is conducted at the at the Department of Plastic Surgery (Sechenov University, Moscow), and at the Department of Reconstructive and Plastic Surgery (Lancet Clinic, Moscow), with all patients recruited through a single surgical team and all imaging performed at a single institution.
Study population. The investigators plan to conduct a pilot phase of this study using non-contrast MRA in 100 patients and to compare imaging modalities used in deep inferior epigastric perforator flap breast reconstruction (computed tomography angiography with contrast, n=35 and non-contrast magnetic resonance angiography, n=100). Power analysis determine that no less than 35 patients in control group in this study considering 80 % power with 95 % significance. The first group (experimental, MRA "-" group) will be included patients who refused computed tomography angiography (CTA) with contrast due to a number of reasons such as fear of contrast agent administration, history of iodine allergy, fear of radiation exposure, etc was underwent MRA without contrast, and the second group (control, CTA "+" group) will be involved iodine-tolerance patients with healthy kidneys who underwent preoperative planning with a standard technique - CTA with IV iodine-containing contrast injection.
Interventions. Participants in first group (experimental, MRA "-" group) underwent preoperative planning with a contrast-free magnetic resonance angiography (MRA) using an improved contrast-free MRA protocol. MRA was performed on a magnetic resonance machine Philips Ingenia 1.5 T (Royal Philips, Netherlands). High accuracy is achieved by the following actions: certain preprocedural patient's preparation and positioning, special pulse scanning sequence and perforators projection method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A female patients who underwent unilateral mastectomy due to breast cancer, in remission.
- •At least 1 year after completion of radiotherapy.
- •Non-inclusion Criteria:
- •A history of abdominal donor site free flaps or abdominoplasty.
- •Inability to give consent.
- •The expander with magnetic ports, claustrophobia, pregnancy and breastfeeding.
- •Patients with severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes
- •The presence of psychiatric illness preventing participation in the study.
排除标准
- •Patient's pregnancy diagnosed during the research period.
- •Patient's refusal of surgery, patient's refusal of further participation in the study.
- •The presence of concomitant diseases preventing participation in the study.
结局指标
主要结局
The concordance ratio.
时间窗: During the surgery.
The investigators are use the information about each perforators' deviation (P1, P2, etc.) based on intraoperative finding (confirmation) and MRA or CTA data by more/less than 1 cm. Intraoperatively, the surgeon determined the distance from the umbilicus to the perforator vessel (by dropping a perpendicular line from umbilicus) and the distance from the point marked on the marking according to the MRA or CTA data to the found perforator vessel. Measurements performed using a 200 mm surgical ruler (Devemed, Germany).
The overall operation time (min).
时间窗: Immediately after the surgery.
The total operating time including downtime.
The time of the pedicle cut (min).
时间窗: During the surgery.
The investigators plan to evaluate the time of the pedicle cut from the beginning of surgery and from flap harvest, for the right and left vascular pedicle individually.
Intraoperative evaluation of flap perfusion.
时间窗: During the surgery.
The flap perfusion was assessed for capillary refill after the vascular pedicle clipping, after the vascular pedicle cutting, and at the end of the flap ischemia time (after the microvascular anastomosis formation) by applying mild pressure, using a hemostat handle. Pressure was then released and the flap observed for capillary refill. Refill was deemed positive if it occurred within 3 s.
Postoperative flap necrosis (%).
时间窗: During the first week after surgery.
The presence of flap necrosis was assessed during the first five days after surgery by evaluating capillary refill in thee flap and visually assessed the presence of the flap ischemia or necrosis as a percentage of the total flap.
The length of the fascia incision (cm).
时间窗: During the surgery.
Intraoperatively, the surgeon measured the fascia incision length using a 200 mm surgical ruler (Devemed, Germany).
次要结局
- The length of the vascular pedicle (cm).(During the surgery.)
- The number of perforators included in the flap.(Immediately after the surgery.)
- The flap ischemia time (min).(During the surgery.)
- Inclusion of superficial vein(s) in the flap.(Immediately after the surgery.)