A Prospective, Open, Single Center, Study of One-day Diagnostic Track for Lung Cancer Suspects From Chest X-ray Using PET-CT and Subsequent Multiple Endoscopic Investigations. (Including Bronchoscopy, EUS-FNA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Isala
- 入组人数
- 297
- 试验地点
- 1
- 主要终点
- Number of patients that will have a definitive diagnosis and final stage NSCLC in one day
研究概览
简要总结
Patients who are admitted to the outpatient pulmonology department by a general practitioner or specialist with a chest X-ray suspicious for lung cancer with an age between 18 and 80 years are suitable for participation. The X-ray and referral are studied by a chest physician (by phone or fax ). Selected patients are invited to enter the study after answering a questionnaire by phone (p. 31). The questionnaire screens patients' interest, co-morbidity and medication use. Informed consent forms, patient information forms and a time table for the diagnostic day are provided by mail or E-mail in cases where time gets short. Waiting time to enter the study will be no longer than one week.
Hundred patients will be recruited by means of informed consent. Patients will be admitted at the pulmonary ward for the study day and will be accompanied by nurses. All patients will get PET-CT scanning in the morning of the study day. Depending on the location of lesions seen on PET-CT, further invasive diagnostic procedures will be planned for the afternoon.
Mediastinal and adjacent structures will be analysed with EUS-FNA. Mediastinal staging will be done with bronchoscopy alone for central located tumors, peripherally located lesions will be analysed with EUS-FNA or bronchoscopy.
The percentage of patients in which this diagnostic track leads to a diagnosis and tumor stage in one day will be determined. The number of tests and diagnostic procedures needed to obtain a diagnosis, including tumor stage (especially final stage NSCLC) and function tests, will be compared with a historical matched study group. This historical study group is chosen from an era before the availability of integrated PET-CT and ultrasound guided endoscopic tools and meets the same inclusion and exclusion criteria as the patients in this study. The timelines from initial chest X-ray to diagnostic day to informing the patient to start of treatment will be determined. These figures will be compared with the historical study group.
详细描述
Background of the study:
Patients have to pass different diagnostic phases in their analysis of a chest X-ray suspicious for lung cancer. Long waiting times with uncertainty about the outcome are a waste of time and unacceptable for the patient. Hospital visits as a consequence of this are a financial burden. Important reasons for physicians to shorten diagnostic tumor analysis. Shortening and intensifying the diagnostic track by combining diagnostic and staging procedures would preclude unnecessary tests and procedures, lowering the total hospital costs per patient and may lead to more satisfaction for patient and physician.
PET-CT is the most important imaging tool for lung cancer analysis and better than CT or FDG-PET alone, but not optimal for determination of tumour invasion in mediastinal or other adjacent structures. MRI is more suitable for this purpose, but is limited available. EUS-FNA (carinal lymph nodes), eventually in combination with CT or FDG-PET and EBUS-TBNA (right mediastinal lymph nodes), superior to TBNA alone, are novel imaging techniques with a high accuracy. Bronchoscopy provides information on tumour type and resectability of centrally but not peripherally located tumours. Mediastinal staging can be performed by adding TBNA to bronchoscopy with high accuracy. PET-CT, as a superior imaging mode, could direct for the best subsequent endoscopic technique for obtaining a tissue diagnosis as well as leading to a more comprehensive staging of patients with suspected lung cancer.
False negative findings could be caused by sampling errors or false interpretations by the cytopathologist of specimens with tumour cell poverty. A more sensitive immune histochemical analysis could modify EUS-FNA and EBUS-TBNA results.
Objective of the study:
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a suspicion of lung cancer on chest X-ray
- •age between 18-85 years
- •informed consent.
排除标准
- •comorbidity (alcoholabuse, drugsabuse and limiting psychiatric disease)
- •non-compliance
- •previous diagnostic tests for the suspicious X-ray (endoscopy, CT)
结局指标
主要结局
Number of patients that will have a definitive diagnosis and final stage NSCLC in one day
时间窗: 1 day
次要结局
- Number of tests and procedures that have been performed. Patient satisfaction with the one-day procedure. Sensitivity of EUS-FNA and EBUS-TBNA when immunohistochemical analysis is added to investigate false negative procedures.(2 years)