A Randomised Study Evaluating Diagnostics of Pleural Effusion Among Patients Suspect of Cancer.
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|ClinicalTrials.gov Identifier: NCT04233359|
Recruitment Status : Terminated (To few patients recruited to allow for study completion within ph.d. project.)
First Posted : January 18, 2020
Last Update Posted : September 28, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion, Malignant Pleural Effusion Pleura; Exudate||Procedure: Local anesthetic thoracoscopy Procedure: US-guided pleural biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Local Anesthetic Thoracoscopy Versus Ultrasound Guided Pleural Biopsies and Repeat Thoracocentesis in Pleural Effusion After Inconclusive Initial Thoracentesis: a Randomized Study|
|Actual Study Start Date :||December 20, 2019|
|Actual Primary Completion Date :||September 24, 2020|
|Actual Study Completion Date :||September 24, 2020|
Active Comparator: US-guided pleural biopsy and thoracentesis
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.
Procedure: US-guided pleural biopsy
In local anesthesia, a closed needle biopsy is performed Ultrasound guided of the parietal pleura at the place of deepest fluid recess in the intrathoracic space. A pigtail catheter French 7-16 is placed afterwards for fluid drainage.
Experimental: 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.
Procedure: Local anesthetic thoracoscopy
Procedure to obtain histological biopsies of the parietal pleura on awake, fastening patients.
Other Name: medical thoracoscopy
- Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate, local anesthetic thoracoscopy vs 2. thoracentesis [ Time Frame: 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. [ Time Frame: 26 weeks ]Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus US-guided pleural biopsy prior to 2nd thoracentesis
- Incidence of achieving pleural immunohistochemistry, mutations, oncodrivers, culture and biochemistry. [ Time Frame: 26 weeks ]
- Incidence of completed procedures [ Time Frame: 1 week ]
- Time from randomization to conclusive, treatment-guiding diagnoses [ Time Frame: 26 weeks ]
- Time from start of consultation with medical staff until end of consultation with medical staff on the day of the procedure [ Time Frame: Day of procedure/intervention ]
- Time from procedure start to patient leaving the procedure room and leaving the recovery room [ Time Frame: Day of procedure/intervention ]
- Adverse event; complication to procedure: mortality [ Time Frame: 30 days. ]Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system
- Adverse event; complication to procedure: pneumothorax [ Time Frame: 30 days. ]Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system
- Adverse event; complication to procedure: haemoptysis [ Time Frame: 30 days. ]Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system
- Adverse event; complication to procedure: infection [ Time Frame: 30 days. ]
- Adverse event; complication to procedure: hospital admission [ Time Frame: 30 days. ]
- Total volume of pleural fluid removed [ Time Frame: Day of procedure ]In mililiter (ml)
- Patient reported discomfort reported via ESAS [ Time Frame: Day of procedure pre- and post-procedure and 1 week followup ]ESAS - Edmonton Symptom Assesment System, Danish Version 2008
- Patient reported discomfort reported via EQ-5D-5L [ Time Frame: Day of procedure pre- and post-proceudre and 1 week followup ]Denmark (Danish) © 2009 EuroQol Group EQ-5D™
- Willingness to repeat procedure [ Time Frame: After procedure performed - within 30 minutes and 1 week after proceudre ]5 Point Likert Scale, 1 not likely to repeat, 5 most likely to repeat
- Cough [ Time Frame: Pre-procedure, 1 week post procedure. ]Visual analogue scale 1-10. 1 Being no cough, 10 being extreme cough
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04233359
|Næstved, Denmark, 4700|
|University Hospital Zealand, Roskilde|
|Roskilde, Denmark, 4000|
|Study Chair:||Uffe Bødtger, MD ph.d.||Næstved|