Pleural Effusion, MalignantNCT04233359
A Randomised Study Evaluating Diagnostics of Pleural Effusion Among Patients Suspect of Cancer.
A study testing Local anesthetic thoracoscopy and US-guided pleural biopsy in people with Pleural Effusion, Malignant and Pleural Effusion, run by Naestved Hospital at 2 sites in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion, Malignant, Pleural Effusion, Pleura; Exudate
- What is being tested?
- Local anesthetic thoracoscopy and US-guided pleural biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Dec 2019to 24 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 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Næstved Hospital
Næstved, 4700
University Hospital Zealand, Roskilde
Roskilde, 4000
About this study
Official title: Local Anesthetic Thoracoscopy Versus Ultrasound Guided Pleural Biopsies and Repeat Thoracocentesis in Pleural Effusion After Inconclusive Initial Thoracentesis: a Randomized Study
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:
Read more
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.
- Being tested
- Local anesthetic thoracoscopy, US-guided pleural biopsy
- Keywords
- Pleural effusion, Malignant Pleural effusion, Pleura diagnostics, US-guided pleural biopsy, Local anesthetic thoracoscopy
- Medical subject headings
- Pleural Effusion, Malignant, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthetic thoracoscopyProcedure or surgery
Also called medical thoracoscopy
Procedure to obtain histological biopsies of the parietal pleura on awake, fastening patients.
US-guided pleural biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| US-guided pleural biopsy and thoracentesis | Active comparator | 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. Receives: Procedure: US-guided pleural biopsy |
| LAT and thoracentesis | Experimental | 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. Receives: Procedure: Local anesthetic thoracoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26 weeks
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
Measured: 26 weeks
Secondary outcomes (15)
Incidence of achieving pleural immunohistochemistry, mutations, oncodrivers, culture and biochemistry.
Measured: 26 weeks
Incidence of completed procedures
Measured: 1 week
Time from randomization to conclusive, treatment-guiding diagnoses
Measured: 26 weeks
Time from start of consultation with medical staff until end of consultation with medical staff on the day of the procedure
Measured: Day of procedure/intervention
Time from procedure start to patient leaving the procedure room and leaving the recovery room
Measured: Day of procedure/intervention
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
Measured: 30 days.
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
Measured: 30 days.
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
Measured: 30 days.
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
Measured: 30 days.
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
Measured: 30 days.
Total volume of pleural fluid removed
In mililiter (ml)
Measured: Day of procedure
Patient reported discomfort reported via ESAS
ESAS - Edmonton Symptom Assesment System, Danish Version 2008
Measured: Day of procedure pre- and post-procedure and 1 week followup
Patient reported discomfort reported via EQ-5D-5L
Denmark (Danish) © 2009 EuroQol Group EQ-5D™
Measured: Day of procedure pre- and post-proceudre and 1 week followup
Willingness to repeat procedure
5 Point Likert Scale, 1 not likely to repeat, 5 most likely to repeat
Measured: After procedure performed - within 30 minutes and 1 week after proceudre
Cough
Visual analogue scale 1-10. 1 Being no cough, 10 being extreme cough
Measured: Pre-procedure, 1 week post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Dec 2019
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Why it stopped: To few patients recruited to allow for study completion within ph.d. project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Pleural Effusion, MalignantStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naestved Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uffe Bødtger, MD ph.d., Study chair, Næstved
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233359
- Sponsor's protocol ID
- SJ-790
- Status last verified
- Sep 2020
- First submitted
- 15 Jan 2020
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saks AM, Posner R. Tuberculosis in HIV positive patients in South Africa: a comparative radiological study with HIV negative patients. Clin Radiol. 1992 Dec;46(6):387-90. doi: 10.1016/s0009-9260(05)80684-1.
PubMed 1493651Arnold DT, De Fonseka D, Perry S, Morley A, Harvey JE, Medford A, Brett M, Maskell NA. Investigating unilateral pleural effusions: the role of cytology. Eur Respir J. 2018 Nov 8;52(5):1801254. doi: 10.1183/13993003.01254-2018. Print 2018 Nov.
PubMed 30262573Porcel JM, Esquerda A, Vives M, Bielsa S. Etiology of pleural effusions: analysis of more than 3,000 consecutive thoracenteses. Arch Bronconeumol. 2014 May;50(5):161-5. doi: 10.1016/j.arbres.2013.11.007. Epub 2013 Dec 20. English, Spanish.
PubMed 24360987Marel M, Zrustova M, Stasny B, Light RW. The incidence of pleural effusion in a well-defined region. Epidemiologic study in central Bohemia. Chest. 1993 Nov;104(5):1486-9. doi: 10.1378/chest.104.5.1486.
PubMed 8222812Bintcliffe OJ, Lee GY, Rahman NM, Maskell NA. The management of benign non-infective pleural effusions. Eur Respir Rev. 2016 Sep;25(141):303-16. doi: 10.1183/16000617.0026-2016.
PubMed 27581830Hooper C, Lee YC, Maskell N; BTS Pleural Guideline Group. Investigation of a unilateral pleural effusion in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii4-17. doi: 10.1136/thx.2010.136978. No abstract available.
PubMed 20696692Porcel JM, Gasol A, Bielsa S, Civit C, Light RW, Salud A. Clinical features and survival of lung cancer patients with pleural effusions. Respirology. 2015 May;20(4):654-9. doi: 10.1111/resp.12496. Epub 2015 Feb 23.
PubMed 25706291Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii32-40. doi: 10.1136/thx.2010.136994. No abstract available.
PubMed 20696691Orki A, Akin O, Tasci AE, Ciftci H, Urek S, Falay O, Kutlu CA. The role of positron emission tomography/computed tomography in the diagnosis of pleural diseases. Thorac Cardiovasc Surg. 2009 Jun;57(4):217-21. doi: 10.1055/s-2008-1039314. Epub 2009 May 20.
PubMed 19670115Naito T, Satoh H, Ishikawa H, Yamashita YT, Kamma H, Takahashi H, Ohtsuka M, Hasegawa S. Pleural effusion as a significant prognostic factor in non-small cell lung cancer. Anticancer Res. 1997 Nov-Dec;17(6D):4743-6.
PubMed 9494600Nance KV, Shermer RW, Askin FB. Diagnostic efficacy of pleural biopsy as compared with that of pleural fluid examination. Mod Pathol. 1991 May;4(3):320-4.
PubMed 2068057Loddenkemper R, Boutin C. Thoracoscopy: present diagnostic and therapeutic indications. Eur Respir J. 1993 Nov;6(10):1544-55.
PubMed 8112449Garcia LW, Ducatman BS, Wang HH. The value of multiple fluid specimens in the cytological diagnosis of malignancy. Mod Pathol. 1994 Aug;7(6):665-8.
PubMed 7991525Koegelenberg CF, Irusen EM, von Groote-Bidlingmaier F, Bruwer JW, Batubara EM, Diacon AH. The utility of ultrasound-guided thoracentesis and pleural biopsy in undiagnosed pleural exudates. Thorax. 2015 Oct;70(10):995-7. doi: 10.1136/thoraxjnl-2014-206567. Epub 2015 May 21.
PubMed 25997433Light 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 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthetic Thoracoscopy Versus Ultrasound Guided Pleural Biopsies and Repeat Thoracocentesis in Pleural Effusion After Inconclusive Initial Thoracentesis: a Randomized Study
- ClinicalTrials.gov ID
- NCT04233359
- Acronym / sponsor ID
- SJ-790
- Keywords
- Pleural effusion, Malignant Pleural effusion, Pleura diagnostics, US-guided pleural biopsy, Local anesthetic thoracoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To few patients recruited to allow for study completion within ph.d. project.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Naestved HospitalUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 18 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided pleural biopsy and thoracentesis | Active comparator | Procedure: US-guided pleural biopsyPleural 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. |
| LAT and thoracentesis | Experimental | Procedure: Local anesthetic thoracoscopyLocal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Local anesthetic thoracoscopyAlso: medical thoracoscopyProcedure to obtain histological biopsies of the parietal pleura on awake, fastening patients. | Procedure or surgery | LAT and thoracentesis |
| US-guided pleural biopsyIn 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. | Procedure or surgery | US-guided pleural biopsy and thoracentesis |
Primary outcome
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
15 secondary outcomes
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.
Adverse event; complication to procedure: pneumothorax
Time frame: 30 days.
Adverse event; complication to procedure: haemoptysis
Time frame: 30 days.
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
Patient reported discomfort reported via ESAS
Time frame: Day of procedure pre- and post-procedure and 1 week followup
Patient reported discomfort reported via EQ-5D-5L
Time frame: Day of procedure pre- and post-proceudre and 1 week followup
Willingness to repeat procedure
Time frame: After procedure performed - within 30 minutes and 1 week after proceudre
Cough
Time frame: Pre-procedure, 1 week post procedure.
Results and safety
The study was stopped early (reason given: To few patients recruited to allow for study completion within ph.d. project.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Background: PubMed 1493651Saks AM, Posner R. Tuberculosis in HIV positive patients in South Africa: a comparative radiological study with HIV negative patients. Clin Radiol. 1992 Dec;46(6):387-90. doi: 10.1016/s0009-9260(05)80684-1.
- Background: PubMed 30262573Arnold DT, De Fonseka D, Perry S, Morley A, Harvey JE, Medford A, Brett M, Maskell NA. Investigating unilateral pleural effusions: the role of cytology. Eur Respir J. 2018 Nov 8;52(5):1801254. doi: 10.1183/13993003.01254-2018. Print 2018 Nov.
- Background: PubMed 24360987Porcel JM, Esquerda A, Vives M, Bielsa S. Etiology of pleural effusions: analysis of more than 3,000 consecutive thoracenteses. Arch Bronconeumol. 2014 May;50(5):161-5. doi: 10.1016/j.arbres.2013.11.007. Epub 2013 Dec 20. English, Spanish.
- Background: PubMed 8222812Marel M, Zrustova M, Stasny B, Light RW. The incidence of pleural effusion in a well-defined region. Epidemiologic study in central Bohemia. Chest. 1993 Nov;104(5):1486-9. doi: 10.1378/chest.104.5.1486.
- Background: PubMed 27581830Bintcliffe OJ, Lee GY, Rahman NM, Maskell NA. The management of benign non-infective pleural effusions. Eur Respir Rev. 2016 Sep;25(141):303-16. doi: 10.1183/16000617.0026-2016.
- Background: PubMed 20696692Hooper C, Lee YC, Maskell N; BTS Pleural Guideline Group. Investigation of a unilateral pleural effusion in adults: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii4-17. doi: 10.1136/thx.2010.136978. No abstract available.
- Background: PubMed 25706291Porcel JM, Gasol A, Bielsa S, Civit C, Light RW, Salud A. Clinical features and survival of lung cancer patients with pleural effusions. Respirology. 2015 May;20(4):654-9. doi: 10.1111/resp.12496. Epub 2015 Feb 23.
- Background: PubMed 20696691Roberts ME, Neville E, Berrisford RG, Antunes G, Ali NJ; BTS Pleural Disease Guideline Group. Management of a malignant pleural effusion: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii32-40. doi: 10.1136/thx.2010.136994. No abstract available.
- Background: PubMed 19670115Orki A, Akin O, Tasci AE, Ciftci H, Urek S, Falay O, Kutlu CA. The role of positron emission tomography/computed tomography in the diagnosis of pleural diseases. Thorac Cardiovasc Surg. 2009 Jun;57(4):217-21. doi: 10.1055/s-2008-1039314. Epub 2009 May 20.
- Background: PubMed 9494600Naito T, Satoh H, Ishikawa H, Yamashita YT, Kamma H, Takahashi H, Ohtsuka M, Hasegawa S. Pleural effusion as a significant prognostic factor in non-small cell lung cancer. Anticancer Res. 1997 Nov-Dec;17(6D):4743-6.
- Background: PubMed 2068057Nance KV, Shermer RW, Askin FB. Diagnostic efficacy of pleural biopsy as compared with that of pleural fluid examination. Mod Pathol. 1991 May;4(3):320-4.
- Background: PubMed 8112449Loddenkemper R, Boutin C. Thoracoscopy: present diagnostic and therapeutic indications. Eur Respir J. 1993 Nov;6(10):1544-55.
- 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 ph.d. study chair
Næstved
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthetic thoracoscopy and US-guided pleural biopsy in people with Pleural Effusion, Malignant and 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 6 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 28 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: To few patients recruited to allow for study completion within ph.d. project.). 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?
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). The study lists 2 primary outcomes in all. 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 NCT04233359, which also lists 30 linked publications.
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 28 Sep 2020.