Malignant Pleural EffusionNCT04236037
Ultrasound-guided Biopsy of the Pleura as a Supplement to Extraction of Fluid in Patients With One-sided Fluid in the Pleura
A study testing ultrasound-guided pleural biopsy and Thoracentesis in people with Malignant Pleural Effusion and Exudative Pleural Effusion, run by Naestved Hospital at 2 sites in Denmark.
Trial summary
The research group will investigate the diagnostic effect of early introduction of ultrasound guided pleural biopsy in the work-up of patients with one-sided pleural effusion, suspected of malignant pleural effusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion, Exudative Pleural Effusion
- What is being tested?
- ultrasound-guided pleural biopsy and Thoracentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesDenmark
- Study dates
- 11 Nov 2019to 23 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Patients with a previous thoracentesis of a unilateral exudative pleural effusion according to Light's criteria (1) without malignant cells.
- CT thorax or PET-CT with contrast performed.
- Clinical suspicion of cancer such as (but not limited to) weight loss or PET-CT results or former cancer diagnosis.
- Patients must be able to give informed consent.
Who cannot join
- Bilateral pleural effusions.
- Known cause of pleural effusions.
- Life expectancy <3 months.
- Inability to understand written or spoken Danish.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Næstved Sygehus, department of pulmonary medicine
Næstved, Region Sjælland, 4700
Zealand University Hospital, Roskilde, Department of Pulmonary medicine
Roskilde, Region Sjælland, 4000
About this study
Official title: Ultrasound-guided Pleural Biopsy as a Supplement to Thoracentesis: A Randomised Study
The research group will investigate the diagnostic effect of early introduction of ultrasound guided pleural biopsy in the work-up of patients with one-sided pleural effusion, suspected of malignant pleural effusion.
Read the detailed description
Patients with unilateral pleural effusion with high protein content (exudative pleural effusion) are likely to have malignant pleural effusion. In the Danish guidelines, patient undergo two thoracentesis before more invasive procedures, due to the relatively low incidens of pleural TB and mesothelioma. The aim of the research group is to investigate the effect of early introduction of ultrasound-guided pleural biopsy taken at the optimal sport for thoracentesis. The research group will randomise half of our patients with unilateral pleural exudate to up-front ultrasound-guided biopsy and the other half usual care eg. a second thoracentesis, to see if there is a benefit of early pleural biopsy in the work-up of patients with unilateral pleural effusion, suspected of malignant pleural effusion.
- Being tested
- ultrasound-guided pleural biopsy, Thoracentesis
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided pleural biopsyProcedure or surgery
Using ultrasound the optimal point of entry for thoracentesis is located. Local anesthesia is obtained with 10 mL of 2% lidocaine with adrenalin injected in cutis, subcutis, muscle and pleura. Before removing the syringe, aspiration of pleural fluid confirms the relevance of the chosen site . Again, the area is wiped with disinfectant and a millimeter small skin incision is made with a pointed scalpel. Six US-guided biopsies of 1.2 millimetres using closed needle biopsies (Quick-core Biopsy Needle 18G, COOK Medical, Bloomington, Indiana, USA or Bard Max Core needle 18G, Temple, Arizona, USA). ) are taken from the parietal pleura. Thoracentesis is performed as described above using the same incision as the pleural biopsy.
ThoracentesisProcedure or surgery
The optimal point of entry (the largest distance between parietal and visceral pleura) is identified using ultrasound. This is usually on the lower, dorsal side of the chest. Local anesthesia is obtained with 10 mL of 2% lidocaine with adrenalin injected in cutis, subcutis, muscle and pleura. Before removing the syringe, aspiration of pleural fluid confirms the relevance of the chosen site. The area is wiped with disinfectant and a millimeter skin incision is made with a pointed scalpel. A 7 French (or up to 16 French, to the choice of the clinician) pigtail catheter is inserted and connected to sealed bag. Fluid is aspirated via a 3-way valve, and transferred to relevant bottles for culture, analysis of albumin and LDH, protein, and for cytology.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided thoracentesis | Active comparator | Ultrasound guided thoracentesis Receives: Procedure: Thoracentesis |
| Ultrasound-guided pleural biopsy and thoracentesis | Experimental | Ultrasound-guided biopsy of the parietal pleura is taken through the same incision as the optimal site for thoracentesis and immediately prior to ultrasound-guided thoracentesis Receives: Procedure: ultrasound-guided pleural biopsy; Procedure: Thoracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cases with conclusive pleural workup to provide and plan treatment in patients diagnosed with malignant pleural effusion.
Our primary endpoint includes both patients who will receive palliative care and patients who will receive active treatment. For patients receiving palliative care, the presence of malignant cells is sufficient. However, for patients receiving active treatment, the primary endpoint is defined as a definite and treatment-guiding pathological result (immunohistochemistry, mutations, oncodrivers, culture and biochemistry) as decided by a multidisciplinary team conference.
Measured: 26 weeks post randomization
Secondary outcomes (16)
Proportion of cases achieving pleural immunohistochemistry, mutations, oncodrivers and culture.
Measured: 26 weeks post randomization
Difference in diagnostic yield between Arm A and Arm B, including subgroup analysis of MPE.
Measured: 26 weeks post randomization
Sensitivity of ultrasound-guided closed needle biopsy of parietal pleura for diagnosing malignancy and all causes of PE.
Measured: 26 weeks post randomization
Time from inclusion to conclusive, treatment-guiding diagnoses in patients with MPE.
Measured: 26 weeks post randomization
The negative likelihood ratio of additional ultrasound-guided closed needle biopsy of parietal pleura in aspect of MPE.
Measured: 26 weeks post randomization
Proportion of true non-malignant PE at end of follow-up.
Measured: 26 weeks post randomization
Complications to pleural procedures
mortality, pneumothorax, haemoptysis, local bleeding, infections and hospital admissions
Measured: Day 1 (1 hour after the end of procedure), 7 days and 30 days post-procedure
Mean volume pleural fluid drained during thoracentesis
measured in mL
Measured: Day 1 within 30 minutes after the end of procedure
Patient reported discomfort and health
measured by 5Q-5D-5L (2009 EuroQol Group EQ-5D™ Danish version).
Measured: Day 1within 30 minutes after the end of procedure and 7 days post-procedure
Patient reported discomfort and health
Measured by Edmonton Symptom Assessment System (ESAS), scale 1-10, 0 being no symptoms, 10 being the worse symptoms
Measured: Day 1 (immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure
Patient reported cough
VAS score (visual analogue scale) for cough, 0-10, 0 being no cough, 10 being the worse cough
Measured: Day 1(immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure
Pain during procedure
Measured by VAS score (visual analogue scale) for pain, 0-10, 0 being no pain, 10 being the worse pain
Measured: Day 1(within 30 minutes after the end of procedure)
Willingness to repeat the procedure
Measured by 5-point Likert scale,scale 1-5, 1 being definitely willing to have the procedure again, 5 being definitely not willing to have the procedure performed again
Measured: day og procedure (within 30 minutes after the end of procedure) and 1 week post-procedure
Change in patient reported discomfort
iMeasured by Edmonton Symptom Assessment System (ESAS) and VAS score (visual analogue scale) for cough
Measured: Day 1 within 30 minutes after the end of procedure
Changes in patient reported discomfort and health
Measured by Edmonton Symptom Assessment System (ESAS) and VAS score (visual analogue scale) for cough and health measured by 5Q-5D-5L (2009 EuroQol Group EQ-5D™ Danish version).
Measured: 7 days post-procedure
Number of thoracenteses in these 7 days besides the study procedure.
Measured: 7 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start11 Nov 2019
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Why it stopped: It is unrealistic to succeed with sufficient inclusion within the timeframe of the study, why it is terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uffe Bødtger, MD, PhD,, Principal investigator, Department of Respiratory Medicine; Naestved Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236037
- Sponsor's protocol ID
- SJ-787
- Status last verified
- Sep 2020
- First submitted
- 31 Oct 2019
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Light RW, Macgregor MI, Luchsinger PC, Ball WC Jr. Pleural effusions: the diagnostic separation of transudates and exudates. Ann Intern Med. 1972 Oct;77(4):507-13. doi: 10.7326/0003-4819-77-4-507. No abstract available.
PubMed 4642731
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Pleural Biopsy as a Supplement to Thoracentesis: A Randomised Study
- ClinicalTrials.gov ID
- NCT04236037
- Acronym / sponsor ID
- SJ-787
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It is unrealistic to succeed with sufficient inclusion within the timeframe of the study, why it is terminated.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research group will investigate the diagnostic effect of early introduction of ultrasound guided pleural biopsy in the work-up of patients with one-sided pleural effusion, suspected of malignant pleural effusion.
Detailed description
Patients with unilateral pleural effusion with high protein content (exudative pleural effusion) are likely to have malignant pleural effusion. In the Danish guidelines, patient undergo two thoracentesis before more invasive procedures, due to the relatively low incidens of pleural TB and mesothelioma. The aim of the research group is to investigate the effect of early introduction of ultrasound-guided pleural biopsy taken at the optimal sport for thoracentesis. The research group will randomise half of our patients with unilateral pleural exudate to up-front ultrasound-guided biopsy and the other half usual care eg. a second thoracentesis, to see if there is a benefit of early pleural biopsy in the work-up of patients with unilateral pleural effusion, suspected of malignant pleural effusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided thoracentesis | Active comparator | Procedure: ThoracentesisUltrasound guided thoracentesis |
| Ultrasound-guided pleural biopsy and thoracentesis | Experimental | Procedure: ultrasound-guided pleural biopsy, Procedure: ThoracentesisUltrasound-guided biopsy of the parietal pleura is taken through the same incision as the optimal site for thoracentesis and immediately prior to ultrasound-guided thoracentesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Patients with a previous thoracentesis of a unilateral exudative pleural effusion according to Light's criteria (1) without malignant cells.
- CT thorax or PET-CT with contrast performed.
- Clinical suspicion of cancer such as (but not limited to) weight loss or PET-CT results or former cancer diagnosis.
- Patients must be able to give informed consent.
Key exclusion criteria (4 listed)
- Bilateral pleural effusions.
- Known cause of pleural effusions.
- Life expectancy <3 months.
- Inability to understand written or spoken Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided pleural biopsyUsing ultrasound the optimal point of entry for thoracentesis is located. Local anesthesia is obtained with 10 mL of 2% lidocaine with adrenalin injected in cutis, subcutis, muscle and pleura. Before removing the syringe, aspiration of pleural fluid confirms the relevance of the chosen site . Again, the area is wiped with disinfectant and a millimeter small skin incision is made with a pointed scalpel. Six US-guided biopsies of 1.2 millimetres using closed needle biopsies (Quick-core Biopsy Needle 18G, COOK Medical, Bloomington, Indiana, USA or Bard Max Core needle 18G, Temple, Arizona, USA). ) are taken from the parietal pleura. Thoracentesis is performed as described above using the same incision as the pleural biopsy. | Procedure or surgery | Ultrasound-guided pleural biopsy and thoracentesis |
| ThoracentesisThe optimal point of entry (the largest distance between parietal and visceral pleura) is identified using ultrasound. This is usually on the lower, dorsal side of the chest. Local anesthesia is obtained with 10 mL of 2% lidocaine with adrenalin injected in cutis, subcutis, muscle and pleura. Before removing the syringe, aspiration of pleural fluid confirms the relevance of the chosen site. The area is wiped with disinfectant and a millimeter skin incision is made with a pointed scalpel. A 7 French (or up to 16 French, to the choice of the clinician) pigtail catheter is inserted and connected to sealed bag. Fluid is aspirated via a 3-way valve, and transferred to relevant bottles for culture, analysis of albumin and LDH, protein, and for cytology. | Procedure or surgery | Ultrasound-guided pleural biopsy and thoracentesis, Ultrasound-guided thoracentesis |
Primary outcome
Proportion of cases with conclusive pleural workup to provide and plan treatment in patients diagnosed with malignant pleural effusion.
Time frame: 26 weeks post randomization
Our primary endpoint includes both patients who will receive palliative care and patients who will receive active treatment. For patients receiving palliative care, the presence of malignant cells is sufficient. However, for patients receiving active treatment, the primary endpoint is defined as a definite and treatment-guiding pathological result (immunohistochemistry, mutations, oncodrivers, culture and biochemistry) as decided by a multidisciplinary team conference.
16 secondary outcomes
Proportion of cases achieving pleural immunohistochemistry, mutations, oncodrivers and culture.
Time frame: 26 weeks post randomization
Difference in diagnostic yield between Arm A and Arm B, including subgroup analysis of MPE.
Time frame: 26 weeks post randomization
Sensitivity of ultrasound-guided closed needle biopsy of parietal pleura for diagnosing malignancy and all causes of PE.
Time frame: 26 weeks post randomization
Time from inclusion to conclusive, treatment-guiding diagnoses in patients with MPE.
Time frame: 26 weeks post randomization
The negative likelihood ratio of additional ultrasound-guided closed needle biopsy of parietal pleura in aspect of MPE.
Time frame: 26 weeks post randomization
Proportion of true non-malignant PE at end of follow-up.
Time frame: 26 weeks post randomization
Complications to pleural procedures
Time frame: Day 1 (1 hour after the end of procedure), 7 days and 30 days post-procedure
Mean volume pleural fluid drained during thoracentesis
Time frame: Day 1 within 30 minutes after the end of procedure
Patient reported discomfort and health
Time frame: Day 1within 30 minutes after the end of procedure and 7 days post-procedure
Patient reported discomfort and health
Time frame: Day 1 (immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure
Patient reported cough
Time frame: Day 1(immediately before procedure and within 30 minutes after the end of procedure) and 7 days post-procedure
Pain during procedure
Time frame: Day 1(within 30 minutes after the end of procedure)
Willingness to repeat the procedure
Time frame: day og procedure (within 30 minutes after the end of procedure) and 1 week post-procedure
Change in patient reported discomfort
Time frame: Day 1 within 30 minutes after the end of procedure
Changes in patient reported discomfort and health
Time frame: 7 days post-procedure
Number of thoracenteses in these 7 days besides the study procedure.
Time frame: 7 days post-procedure
Results and safety
The study was stopped early (reason given: It is unrealistic to succeed with sufficient inclusion within the timeframe of the study, why it is terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Background: PubMed 4642731Light RW, Macgregor MI, Luchsinger PC, Ball WC Jr. Pleural effusions: the diagnostic separation of transudates and exudates. Ann Intern Med. 1972 Oct;77(4):507-13. doi: 10.7326/0003-4819-77-4-507. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uffe Bødtger, MD, PhD, principal investigator
Department of Respiratory Medicine; Naestved Hospital, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided pleural biopsy and Thoracentesis in people with Malignant Pleural Effusion and Exudative Pleural Effusion, run by Naestved Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It is unrealistic to succeed with sufficient inclusion within the timeframe of the study, why it is terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cases with conclusive pleural workup to provide and plan treatment in patients diagnosed with malignant pleural effusion. (time frame: 26 weeks post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.