Mediastinal Recurrence of Lympho-proliferative Disorders: a Biopsy is Needed
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- primary outcomes
研究概览
简要总结
We would like to emphasise the need to perform a biopsy in patients with suspected persistence/recurrence of disease; the need to carefully plan the access route to minimise the risk of false negatives; the possibility of performing biopsies through all minimally invasive access routes available to the thoracic surgeon ensuring rapid clinical recovery and timely resumption of medical treatment in the event of recurrence.
详细描述
18 FDG PET is currently the gold standard for the staging of lymphoproliferative disorders such as lymphoma and a routine investigation for re-evaluation after first-line treatment; it is also a well-established re-evaluation modality in case of suspected disease recurrence.
Although FDG-PET/CT has an average sensitivity of 90% and a specificity of 91%, its diagnostic performance in combination with surgical biopsy has not yet been extensively evaluated.(1,2) The high predictive value of a negative PET scan, in the appropriate clinical context, helps to identify those patients with a complete metabolic response and therefore in complete remission.
In contrast, the persistence of metabolic activity (PET positivity) after systemic treatment cannot categorically confirm (or exclude) the presence (or absence) of viable lymphomatous tissue, due to the potential association of inflammatory reactions, which are normally manifested by increased hypercapture on PET scan.
For this reason, the persistence or reappearance of mediastinal hypermetabolic activity, in asymptomatic patients with no signs or symptoms of relapse, requires biopsy confirmation before making a diagnosis of disease relapse.
Current guidelines do not recommend the use of PET for the follow-up of patients in remission after lymphoma therapy due to its limited positive predictive value and considering the unequivocal correlation between hypermetabolic findings and definite disease relapse. However, an aggressive disease, in a district such as the mediastinum - where the rapid growth of a neoplastic disease may exacerbate symptoms of particular relevance due to the occupation of space or due to the infiltration of vital structures - may require a more thorough radiological follow-up including precisely the use of PET. Obviously, the discovery of a hypermetabolic finding in a completely asymptomatic patient requires histological confirmation of the relapse before making the definitive diagnosis of neoplastic recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographic/scintigraphic suspicion of lymphoma persistence/recurrence after cytotoxic treatment Patients undergoing mediastinal biopsy procedure Obtaining informed consent.
排除标准
- •incomplete or missing data
结局指标
主要结局
primary outcomes
时间窗: 30 days after the surgery
Verify the need for histological confirmation in patients undergoing cytotoxic therapy for lymphoma presenting radiological/scintigraphic signs of suspected persistence or mediastinal recurrence of disease.
次要结局
- secondary outcomes(30 days after the surgery)