Rational Approach to a Unilateral Pleural Effusion

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03272087

Acronym

REPEAT

Enrollment

120

Registered

2017-09-05

Start date

2015-05-31

Completion date

2020-12-15

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

Thoracoscopy

Brief 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. 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.

Interventions

DEVICEThoracoscopy

50 % of patients will have performed af medical thoracoscopy (pleuroscopy)

DEVICEVATS (thoracoscopy)

50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of patients diagnosed with cancer	2 years	(cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control).

Secondary

Measure	Time frame	Description
Quality of life	1 month	Questionnaire developed to assess the quality of life of cancer patients, QLQC 30
Total costs	2 years	calculated as costs patient-related, procedure-related, and overall
Pain	2 years	VAS scale

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026