Rational Approach to a Unilateral Pleural Effusion2

Lung Neoplasms Clinical Trial

— REPEAT  

Official title:

Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02834455
• Other study ID #: Resp-REPEAT-SIRE
• Status: Terminated
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 15, 2020

Study information

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

Clinical Trial Summary

Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is difficult, as the pleural surface is large and <33% of pleural malignancies shed malignant cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing mutation status for targeted therapies.

Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than conventional CT for detecting malignant lesions >10mm. However, no randomised trial has investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely PET-positive lesions in e.g. colon however, lead to more derived tests than do CT alone.

Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows only sampling from the parietal pleura. To date, no randomised studies have compared medical and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.

The investigators will perform two randomized studies to investigate whether

1. PET/CT is comparable to CT alone

2. VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with recurrent pleural effusion of unknown origin after a first pleural tap according to BTS guidelines.

2. Indication for thoracoscopy according to BTS guidelines.

3. Patients accept further investigation according to Danish and BTS guidelines.

4. Have received oral and written consent and agreed.

5. At the time of inclusion, above 18 years of age.

Exclusion Criteria:

1. Female patients: pregnancy or breastfeeding.

2. Lack of language comprehension.

3. Legally incompetent patients.

4. Life expectancy less than 3 month.

5. Contraindications to pleural tissue sampling.

Related Conditions & MeSH terms

• Lung Neoplasms
• Pleural Effusion

Intervention

Device:
• Contrast-enhanced CT
50% of patients with unilateral pleural effusion will have performed a CE-CT
• PET-CT
50% of patients with unilateral pleural effusion will have performed a PET-CT

Locations

Country	Name	City	State
Denmark	Naestved Sygehus	Naestved

Sponsors (1)

Lead Sponsor	Collaborator
Simon Reuter

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of diagnostic thoracoscopies (either MT or VATS)		2 years
Secondary	Number of derived investigations (i.e. gastroscopy, coloscopy)		2 years
Secondary	Number of patients diagnosed with cancer (cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control)		2 years
Secondary	Patient satisfaction and patient perceived discomfort	Using QLQC 30	2 years
Secondary	Total costs calculated as costs patient-related, procedure-related, and overall		2 years
Secondary	Total procedures before cancer-diagnosis (cancer = yes/no)		2 years
Secondary	Patient satisfaction and patient perceived discomfort	EuroQol Q-5D a standardised instrument for use as a measure of health outcome	2 years