Indocyanine Green for Perfusion Assessment of DIEP Flaps: A Dutch Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 4
- 主要终点
- Clinical relevant fat necrosis
研究概览
简要总结
Currently during DIEP flap reconstruction, the perfusion of the flap is assessed by the clinical view of the surgeon. Identification of demarcated ischemic zones of the DIEP flap could be optimized by using fluorescence imaging with indocyanine green (ICG) in order to lower the rate of fat necrosis. This study evaluates whether intraoperative perfusion assessment with ICG fluorescence imaging causes a lower rate of fat necrosis compared to conventional intraoperative clinical evaluation of DIEP flaps.
详细描述
Rationale: Autologous breast reconstruction after mastectomy due to cancer or prophylactically due to genetically increased risk is frequently performed. A complication that may occur after a deep inferior epigastric artery (DIEP) reconstruction is the occurrence of fat necrosis in the transplanted flap due to ischemia (reperfusion injury). Identification of deep inferior epigastric artery perforators and identification of demarcated ischemic zones of the DIEP flap can be optimized by using fluorescence imaging with indocyanine green (ICG), as has been demonstrated in previous studies. This could result in less fat necrosis, less partial flap loss, and other complications. A randomized controlled trial would be the best study design to assess the value of ICG in determining the perfusion of DIEP flaps, thereby reducing the occurrence of fat necrosis and other complications.
Objective: To determine whether fluorescence imaging using ICG for the assessment of DIEP flap perfusion during surgery decreases the occurrence of fat necrosis compared to standard intraoperative clinical assessment of DIEP flap perfusion.
Study design: This is a two-armed randomized controlled trial:
- interventional arm: evaluation of flap perfusion based on 1) clinical parameters, and 2) fluorescence imaging using ICG
- conventional arm: evaluation of flap perfusion based on clinical parameters only
Study population: Patients scheduled for elective surgery for autologous breast reconstruction, uni- or bilateral, using DIEP or muscle sparing transverse rectus abdominis muscle (msTRAM) flaps. Female patients 18 years of age and older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participant is blinded for the study arm. A second evaluator of postinterventional fat necrosis is blinded for the study arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 18 years of age and older
- •Who underwent a mastectomy for breast cancer or prophylactic due to genetic predisposition
- •Patients scheduled for elective surgery for autologous breast reconstruction, uni- or bilateral, using DIEP or msTRAM flaps. In case of bilateral breast reconstruction the flaps should be bilateral anastomosed.
- •Written informed consent
排除标准
- •Allergy to ICG, iodine or shellfish
- •Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
- •Impaired renal function defined as eGFR< 50 mL/min/1.73m2 (this can be seen in the standard preoperative lab results)
结局指标
主要结局
Clinical relevant fat necrosis
时间窗: 3 months
Clinically relevant fat necrosis is defined as a palpable mass, either painful or not, and with or without aesthetic complaints, and developed within three months after surgery. The following grading system according to Lie et al. is used. Only grade III till IV is classified as clinical relevant fat necrosis. III: Major compromised reconstructive outcome, flap involvement:15-50%, clinical findings: Major contour defects (multiple), surgical management: Debridement/secondary procedure IV: Subtotal poor reconstructive outcome, flap involvement: \>50%, clinical findings: Skin defects, inadequate volume, volume loss, surgical management: Second local flap/ re-intervention initial flap
次要结局
- Percentage extra resected tissue(1 day)
- Registration of postoperative complications(3 months)
- Personal experience/opinion of surgeon performing surgery with fluorescent imaging using ICG.(1 day)
- Registration of re-interventions(3 months)
- Quantify perfusion of flaps(3 months)
- Duration of surgery in minutes(1 day)
- Patient satisfaction(3 months)
研究者
Alexander Vahrmeijer
Oncologic Surgeon - Hepatobiliary and Colorectal
Leiden University Medical Center