Local Anesthetic Thoracoscopy Versus Ultrasound Guided Pleural Biopsies and Repeat Thoracocentesis in Pleural Effusion After Inconclusive Initial Thoracentesis: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate, local anesthetic thoracoscopy vs 2. thoracentesis
研究概览
简要总结
Pleural fluid can be caused by cancer. Patients with repeated presentation of pleural fluid where initial diagnostic tests have been inconclusive are the focus of this trial. In this clinical trial patients are randomized into two groups and the efficacy of local anesthetic thoracoscopy (LAT) is compared to an ultrasound guided biopsy of the outer lining of the lung. The aim is not only the diagnostic yield in diagnosing cancer, but also the procedures ability to diagnose specific cancer mutations and immune system markings.
Methods and objectives:
Patients with reoccuring one-sided pleural fluid, with a marked clinical risk of cancer based on findings in medical work-up, radiological scans, biochemistry and medical history and who are undiagnosed upon initial pleural fluid analysis are the target patients of the trial. Patients are randomized into two groups to have undertaken either pleural biopsy at the optimal site for a repeat thoracentesis or LAT. Thus diagnostic yield for both fluid analysis and biopsy analysis will be compared to tissue samples taken with LAT.
We hypothesize that LAT is superior both to pleural biopsy and repeat thoracentesis in providing diagnostic clarification and providing sufficient basis for treatment without further procedures resulting in less time consumption, cost and discomfort for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age 18 years or older patients with single previous thoracentesis of a unilateral pleural exudate according to Lights criteria without malignant cells.
- •Lights Criteria:
- •Pleural fluid protein/serum protein ratio greater than 0.5 pleural fluid LDH/serum LDH ratio greater than 0.6 Pleural fluid LDH greater than two-thirds the upper limits of the Laboratorys normal Serum LDH
- •Contrast enhanced CT of the Chest and abdomen performed
- •Clinical suspicion of cancer such as, but not limited to, weight loss, malaise, anemia
- •Pet-CT results or former cancer diagnosis Informed consent
排除标准
- •bilateral pleural effusions
- •known cause of pleural effusion
- •likely non-malignant course of a unilateral pleura effusion such as (but not restricted to) pneumonia, trauma, pleuritis, heart failure
- •any contraindication to the study procedures
研究组 & 干预措施
US-guided pleural biopsy and thoracentesis
Pleural biopsy:
Using ultrasound the optimal point of entry for thoracentesis is located, and local anesthesia is obtained. The area is wiped with disinfectant and a skin incision is made with a pointed scalpel. Six US-guided biopsies of 1x2 millimetres are taken from the parietal pleura using closed needle biopsies (Quick-core Biopsy Needle 18G, COOK Medical, Bloomington, Indiana, USA or Bard Max Core Biopsy Needle 18G, Tempe, Arizona, USA). Afterward, a thoracentesis is performed in the same incision as used by the pleural biopsy. A pigtail catheter is inserted and fastened and connected to a sealed bag and fluid is aspirated and sent to relevant analysis.
干预措施: US-guided pleural biopsy (Procedure)
LAT and thoracentesis
Local anesthetic thoracoscopy: Pre-procedure a pleural pigtail catheter is inserted and pleural fluid is removed. The catheters one-way valve is opened and the patient takes several breaths thereby creating a pneumothorax prior to procedure start. The patient is sedated with midazolam and morphine. Midaxillary access through intercostal space 4-7 is achieved in local anesthesia and via a skin incision a trocar is placed for access to the thoracic space. A semi-rigid thoracoscope (model LTF 160; Olympus, Tokyo, Japan) is inserted via the trocar and the pleural cavity is inspected after removal of residual effusion whereof at least 40ml is sent to cytology. Pleural parietal biopsies are taken under direct visual guidance. The recommended number of biopsies is 10-15. If no abnormalities were seen, random biopsies are taken. After relevant biopsies are taken the instruments are removed the pigtail catheter stays inserted to allow for removal of air and expansion of the lung.
干预措施: Local anesthetic thoracoscopy (Procedure)
结局指标
主要结局
Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate, local anesthetic thoracoscopy vs 2. thoracentesis
时间窗: 26 weeks
Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus 2nd thoracentesis
Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate. Local anesthetic thoracoscopy vs US-guided pleural biopsy.
时间窗: 26 weeks
Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus US-guided pleural biopsy prior to 2nd thoracentesis
次要结局
- Incidence of achieving pleural immunohistochemistry, mutations, oncodrivers, culture and biochemistry.(26 weeks)
- Incidence of completed procedures(1 week)
- Time from procedure start to patient leaving the procedure room and leaving the recovery room(Day of procedure/intervention)
- Adverse event; complication to procedure: pneumothorax(30 days.)
- Patient reported discomfort reported via EQ-5D-5L(Day of procedure pre- and post-proceudre and 1 week followup)
- Cough(Pre-procedure, 1 week post procedure.)
- Adverse event; complication to procedure: haemoptysis(30 days.)
- Patient reported discomfort reported via ESAS(Day of procedure pre- and post-procedure and 1 week followup)
- Time from randomization to conclusive, treatment-guiding diagnoses(26 weeks)
- Time from start of consultation with medical staff until end of consultation with medical staff on the day of the procedure(Day of procedure/intervention)
- Adverse event; complication to procedure: mortality(30 days.)
- Adverse event; complication to procedure: infection(30 days.)
- Adverse event; complication to procedure: hospital admission(30 days.)
- Total volume of pleural fluid removed(Day of procedure)
- Willingness to repeat procedure(After procedure performed - within 30 minutes and 1 week after proceudre)