Prospective Observational Study of Perioperative Biomarkers and Outcomes in Deep Inferior Epigastric Perforator (DIEP) Flap Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Viable DIEP flap area (%) at postoperative day 7
研究概览
简要总结
Brief Summary This observational study will follow patients who undergo DIEP flap breast reconstruction to better understand a common surgical challenge called ischemia-reperfusion (I/R) injury. I/R injury can happen when a flap has a period without blood flow (ischemia) and then blood flow returns (reperfusion). This process may trigger inflammation and oxidative stress and is associated with fat necrosis or partial flap loss.
1. What is being studied
- The investigators will measure inflammation and oxidative stress markers in blood (for example, interleukin-6 [IL-6]) from before surgery through the first 72 hours after surgery.
- These data will help map the normal and abnormal patterns of recovery after surgery and may inform future approaches to monitoring and protecting flap tissue.
- No experimental drug or device is given to participants in this study. Separate animal studies are developing a near-infrared imaging and antioxidant nanomaterial (Mn/QD-SAC); this is not used in participants here.
2. Who can take part
- Women aged 18-70 scheduled for immediate DIEP flap breast reconstruction after breast cancer surgery.
- Key exclusions include severe heart, liver, or kidney disease; significant clotting problems; active infection or autoimmune disease; long-term use of immunosuppressants/anti-inflammatory drugs; pregnancy or breastfeeding; or other reasons judged by the research team.
3. What will happen if you join
- After providing informed consent, participants will have blood drawn at five time points: pre-operative baseline (within 24 hours before surgery) and at 0, 6, 24, and 72 hours after surgery (about 10 mL each time; total ~50 mL).
- Blood will be processed and stored under secure conditions and tested for inflammation and oxidative stress markers.
- The investigators will also record routine clinical information from the medical record (such as age, BMI, surgery duration, ischemia time, and clinical assessments of flap outcomes and complications).
- Participation does not change the participant's clinical care before, during, or after surgery.
4. Risks and benefits
- Risks are those of standard blood draws: brief pain, bruising, bleeding, dizziness, and rare infection.
- There is no direct medical benefit to participants. Results may help improve understanding and future care for patients undergoing flap reconstruction.
5. Privacy and data protection
- Samples and data will be coded without names. Identifying information is stored separately with restricted access.
- Research results are not routinely added to the medical record or returned to participants unless a finding has clear, actionable clinical significance and is approved by the ethics committee.
6. Time commitment and costs
- All blood draws occur during the routine hospital stay. There is no additional follow-up required after discharge.
- There is no cost to participate.
7. Voluntary participation Joining the study is voluntary. Participants may withdraw at any time without affecting their medical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Female, 18-70 years old.
- •Clinically diagnosed with breast cancer and scheduled for immediate DIEP free-flap breast reconstruction after mastectomy.
- •Conscious and able to understand and voluntarily sign written informed consent.
排除标准
- •Severe cardiac, hepatic, or renal dysfunction or severe coagulopathy (e.g., NYHA class III-IV, Child-Pugh class C, eGFR <30 mL/min/1.73 m²).
- •Preoperative active infection, autoimmune disease, or long-term use of immunosuppressants/anti-inflammatory drugs (e.g., corticosteroids).
- •Pregnant or breastfeeding.
- •Prior ipsilateral breast surgery or radiotherapy that may affect local blood circulation assessment.
- •Any condition deemed unsuitable by the investigator (e.g., poor compliance).
研究组 & 干预措施
DIEP flap reconstruction patients (longitudinal peripheral blood cohort)
Prospective observational cohort of women (18-70 years) undergoing immediate autologous breast reconstruction with a DIEP free flap. Standard peri-operative care only; no investigational imaging or drug (no Mn/QD-SAC) is administered. Serial peripheral blood is collected at pre-op baseline (≤24 h) and at 0 h, 6 h, 24 h, and 72 h post-op (≈10 mL/timepoint; serum + EDTA plasma). Primary measurement is plasma IL-6; additional analytes include IL-1β, TNF-α, IL-8, IL-10, IL-18, HMGB1, vWF, VEGF, HIF-1α, MDA, 8-iso-PGF2α, SOD, CAT, GSH-Px, lactate, LDH, PT/APTT/fibrinogen, D-dimer, and CBC. Samples are processed within 2 h and stored at -80°C for batch ELISA/biochemical assays. Clinical data (age, BMI, operative/ischemia times, flap perfusion assessments, complications, fat necrosis/partial flap loss) are recorded. Target enrollment ~30 participants.
结局指标
主要结局
Viable DIEP flap area (%) at postoperative day 7
时间窗: Postoperative day 7
Standardized digital photographs will be obtained on POD7 under uniform lighting and distance with a calibration ruler. Viable flap area (%) is calculated as \[viable area/total area\]×100 using blinded planimetry by two independent raters; discrepancies \>5% are adjudicated by a third rater. This endpoint reflects clinical benefit and flap survival. This is a co-primary endpoint with IL-6; the family-wise error rate is controlled at 0.05 using the Bonferroni correction (two-sided α=0.025 per endpoint).
Plasma interleukin-6 (IL-6) concentration at 24 hours after surgery
时间窗: Baseline (up to 24 hours before surgery) and 24 hours after surgery.
Plasma IL-6 (pg/mL) will be quantified in EDTA plasma using a validated sandwich enzyme-linked immunosorbent assay (ELISA). Blood is drawn up to 24 hours prior to surgery (baseline) and at 24 hours after surgery; plasma is separated within 2 hours, aliquoted, and stored at -80°C (single freeze-thaw). Samples are run in duplicate with a 7-point standard curve and quality control samples. The co-primary analysis will focus on the change in IL-6 from baseline to 24 hours post-surgery, analyzed as a continuous variable with prespecified covariates (age, body mass index, ischemia time, operative duration). This endpoint is co-primary with flap viability; the Bonferroni-adjusted family-wise error rate is 0.05 (two-sided alpha=0.025).
次要结局
- Plasma tumor necrosis factor alpha (TNF-α) concentration at 24 hours after surgery(Baseline (up to 24 hours before surgery) and 24 hours after surgery.)
- Plasma interleukin-10 (IL-10) concentration at 24 hours after surgery(Baseline (up to 24 hours before surgery) and 24 hours after surgery.)
- Area under the curve (AUC) for plasma malondialdehyde from baseline to 24 hours after surgery(Baseline (up to 24 hours before surgery), 6 hours after surgery, and 24 hours after surgery.)
- Area under the curve (AUC) for plasma superoxide dismutase activity from baseline to 24 hours after surgery(Baseline (up to 24 hours before surgery), 6 hours after surgery, and 24 hours after surgery.)
- Area under the curve (AUC) for plasma glutathione peroxidase activity from baseline to 24 hours after surgery(Baseline (up to 24 hours before surgery), 6 hours after surgery, and 24 hours after surgery.)
- Number of participants with surgical site infection within 30 days(From surgery to postoperative day 30)
研究者
Xinhong Wu, PhD
vice-president
Hubei Cancer Hospital