A Randomised Study Evaluating Diagnostics of Pleural Effusion Among Patients Suspect of Cancer.

Pleural Effusion Clinical Trial

Official title:

Local Anesthetic Thoracoscopy Versus Ultrasound Guided Pleural Biopsies and Repeat Thoracocentesis in Pleural Effusion After Inconclusive Initial Thoracentesis: a Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04233359
• Other study ID #: SJ-790
• Status: Terminated
• Phase: N/A
• Start date: December 20, 2019
• Est. completion date: September 24, 2020

Study information

• Verified date: September 2020
• Source: Naestved Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 24, 2020
• Est. primary completion date: September 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pleura; Exudate
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Procedure:
• Local anesthetic thoracoscopy
Procedure to obtain histological biopsies of the parietal pleura on awake, fastening patients.
• 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.

Locations

Country	Name	City	State
Denmark	Næstved Hospital	Næstved
Denmark	University Hospital Zealand, Roskilde	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Naestved Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate, local anesthetic thoracoscopy vs 2. thoracentesis	Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus 2nd thoracentesis	26 weeks
Primary	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.	Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus US-guided pleural biopsy prior to 2nd thoracentesis	26 weeks
Secondary	Incidence of achieving pleural immunohistochemistry, mutations, oncodrivers, culture and biochemistry.		26 weeks
Secondary	Incidence of completed procedures		1 week
Secondary	Time from randomization to conclusive, treatment-guiding diagnoses		26 weeks
Secondary	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
Secondary	Time from procedure start to patient leaving the procedure room and leaving the recovery room		Day of procedure/intervention
Secondary	Adverse event; complication to procedure: mortality	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	30 days.
Secondary	Adverse event; complication to procedure: pneumothorax	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	30 days.
Secondary	Adverse event; complication to procedure: haemoptysis	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	30 days.
Secondary	Adverse event; complication to procedure: infection	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	30 days.
Secondary	Adverse event; complication to procedure: hospital admission	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	30 days.
Secondary	Total volume of pleural fluid removed	In mililiter (ml)	Day of procedure
Secondary	Patient reported discomfort reported via ESAS	ESAS - Edmonton Symptom Assesment System, Danish Version 2008	Day of procedure pre- and post-procedure and 1 week followup
Secondary	Patient reported discomfort reported via EQ-5D-5L	Denmark (Danish) © 2009 EuroQol Group EQ-5D™	Day of procedure pre- and post-proceudre and 1 week followup
Secondary	Willingness to repeat procedure	5 Point Likert Scale, 1 not likely to repeat, 5 most likely to repeat	After procedure performed - within 30 minutes and 1 week after proceudre
Secondary	Cough	Visual analogue scale 1-10. 1 Being no cough, 10 being extreme cough	Pre-procedure, 1 week post procedure.