Pleuroscopy First Versus Thoracentesis First in Patients With Suspected Malignant Pleural Effusions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This is a randomized control trial of patients with suspected malignant pleural effusions to compare whether patients who have a thoracentesis or pleuroscopy (pleural biopsy) obtain an adequate biopsy, achieve a diagnosis, and begin cancer-directed therapy faster.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Referral for diagnostic pleural procedure.
Age ≥ 18 years.
Suspected malignant pleural effusion (Suggestive radiologic appearance (based on computed tomography or positron emission tomography) OR suspected cancer with associated effusion.)
Disqualifiers
Inability to provide informed consent.
Needs emergent drainage.
Pleural effusion is known to be malignant.
Suspected transudative, infectious or inflammatory effusion etiology.
Trial design
Design model
Parallel
Treatments tested in this trial
Pleuroscopy first
Procedure/SurgeryPleuroscopies are performed under moderate sedation with local anesthesia. Through a 1-cm incision a camera is introduced into the pleural space and the space is inspected after draining all fluid. Targeted biopsies under direct visualization are obtained using forceps. The aspirated fluid and biopsies obtained are sent to the cytology and pathology laboratories for analysis.
Thoracentesis first
Procedure/SurgeryThoracenteses are performed under local anesthesia with the insertion of a 5-8Fr catheter into the pleural space. The aspirated fluid obtained is sent to the cytology laboratory for analysis.
Treatment groups
98 Participants
are divided into 2 treatment groupsGroup A: Pleuroscopy firstActive comparator 1 intervention
Group B: Thoracentesis firstActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of biopsies adequate for definitive diagnosis
Proportion of biopsies adequate for definitive diagnosis
Time frame
6 monthsSecondary outcomes
1
Time from initial visit with pulmonologist to procedure
Time from initial visit with pulmonologist to procedure
Time frame
6 months2
Time from initial procedure to diagnosis
Time from initial procedure to diagnosis
Time frame
6 months3
Time from initial visit with pulmonologist to diagnosis
Time from initial visit with pulmonologist to diagnosis
Time frame
6 months4
Time from initial visit with pulmonologist to seeing oncologist
Time from initial visit with pulmonologist to seeing oncologist
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov