Impact of Thymectomy on Immune Response in Infants 12 Months After Cardiac Surgery: a Single-centre Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- T-Lymphocyte response
研究概览
简要总结
Heart surgery in infants typically involves complete removal of the thymus gland to improve access to the heart. However, the thymus plays a key role in developing the immune system in early childhood, especially in the production and maturation of T lymphocytes, which help the body defend itself against infections.
The THYMIC study tests the hypothesis that partial removal of the thymus (partial thymectomy) during heart surgery may better preserve the child's immune function compared to total removal (complete thymectomy). The goal is to determine whether this conservative surgical approach could reduce the risk of immune system impairment and infections in the months following surgery.
This is a prospective, interventional, single-center study conducted at CHU de Nantes, involving 3 groups of infants:
- One group undergoing heart surgery with complete thymectomy;
- One group undergoing heart surgery with partial thymectomy;
- One control group undergoing heart or non-heart surgery without thymus removal. All infants enrolled will have two blood tests: one taken during their surgery and one taken one year later. These blood tests will quantify immune cells (T, B, NK cells), levels of antibodies, and vaccine responses. Parents will also be asked to fill out a questionnaire to record any infections their child experiences during the year after surgery.
By comparing the immune responses and infection rates among the groups, the researchers hope to better understand the long-term effects of thymectomy in infants. The results could support future recommendations to preserve part of the thymus when possible during heart surgery.
Participation in the study does not change the medical or surgical care of the child. The decision to perform a partial or complete thymectomy is made by the surgeon based on the child's anatomy. The additional blood samples are small in volume and follow current safety regulations.
详细描述
The THYMIC study is a prospective, single-center, interventional clinical trial conducted at the University Hospital of Nantes (CHU de Nantes), France. It aims to evaluate the medium-term immunological impact of thymectomy (total versus partial) in infants undergoing cardiac surgery requiring cardiopulmonary bypass (CPB) before the age of 6 months.
Background and Rationale During most pediatric cardiac surgeries, the thymus is completely removed to allow better access to the heart and great vessels. However, the thymus plays a critical role in T-cell development during infancy, contributing to immune system maturation. Prior studies suggest that complete thymectomy in early life may result in persistent alterations in T-cell immunity and increased susceptibility to infections. Yet, the comparative impact of partial versus complete thymectomy on immune function remains poorly studied.
Partial thymectomy is technically feasible in selected cases depending on the anatomy, and could offer a balance between surgical access and immune preservation. The THYMIC study tests the hypothesis that partial thymectomy is associated with less impairment of cellular immunity at 12 months postoperatively and could therefore become the preferred surgical approach in appropriate cases.Study Design
This is a non-randomized, controlled study including 70 infants:
• 50 infants undergoing cardiac surgery with CPB and either partial or complete thymectomy (surgical decision made
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Children aged between 0 and 6 months;
- •Born at a gestational age > 37 weeks' gestation;
- •With an indication for cardiac surgery under CEC at Nantes University Hospital;
- •Cardiopediatric follow-up planned at Nantes University Hospital;
- •Written agreement signed by legal guardians to participate in the study.
- •For the control groups:
- •Control group A (cardiac surgery without thymectomy):
- •Children aged between 0 and 6 months of age;
- •Born at a gestational age > 37 SA;
- •Indicated for thoracotomy cardiac surgery at Nantes University Hospital;
- •Cardiopediatric follow-up planned at Nantes University Hospital;
- •Written agreement signed by legal guardians to participate in the study.
- •Control group B (non-cardiac surgery)
- •Children aged between 0 and 6 months;
- •Born at a gestational age > 37 SA;
- •Indicated for non-cardiac surgery (ENT or visceral surgery at Nantes University Hospital);
- •Planned follow-up surgery at Nantes University Hospital;
- •Written agreement signed by legal guardians to participate in the study.
排除标准
- •Gestational age < 37 SA;
- •With a history of cardiac surgery under ECG;
- •And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).
- •And/or a history of partial or complete thymectomy;
- •Receiving long-term immunosuppressive treatment;
- •Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period;
- •parental refusal.
- •Exclusion Criteria:
- •- Gestational age < 37 SA;
- •With a history of cardiac surgery under ECG;
- •And/or with heart disease requiring further surgery within 12 months of the 1st surgery (e.g. pulmonary cerclage, systemic pulmonary anastomosis).
- •And/or a history of partial or complete thymectomy;
- •Receiving long-term immunosuppressive treatment;
- •Post-operative follow-up planned in a hospital other than Nantes University Hospital, or moving house planned during the follow-up period;
- •parental refusal.
研究组 & 干预措施
Complete Thymectomy Group
Infants undergoing cardiac surgery with cardiopulmonary bypass (CPB), during which a complete thymectomy is performed for surgical access to the heart and great vessels. The extent of thymus resection is determined by the cardiac surgeon intraoperatively, based on anatomical considerations
干预措施: Blood sample collection at surgery time and 12 months later (Diagnostic Test)
Partial Thymectomy Group
Infants undergoing cardiac surgery with CPB, during which a partial thymectomy is performed, with an effort to preserve thymic tissue when anatomically feasible.
干预措施: Blood sample collection at surgery time and 12 months later (Diagnostic Test)
Control Group (No Thymectomy
Infants undergoing:
- Cardiac surgery by thoracotomy without thymectomy (e.g., for aortic coarctation) or
- Non-cardiac surgery (e.g., digestive procedures) with complete preservation of the thymus.
These patients serve as immunological reference controls
干预措施: Blood sample collection at surgery time and 12 months later (Diagnostic Test)
结局指标
主要结局
T-Lymphocyte response
时间窗: 12 months after surgery
biological endpoint with absolute quantification of LyTs, LyT subpopulations and TRECs.
次要结局
- Humoral response(12 months after surgery)
- Clinical impact(12 months after surgery)