Rational Approach to a Unilateral Pleural Effusion2

NCT ID: NCT02834455

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2020-12-15

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.

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.

Conditions

Lung Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CE-CT scanning

Contrast-enhanced CT scan of the thorax and abdomen.

Group Type: ACTIVE_COMPARATOR

Contrast-enhanced CT

Intervention Type: DEVICE

50% of patients with unilateral pleural effusion will have performed a CE-CT

PET-CT scanning

Positron-emission-CT scanning (low dose without contrast) of the thorax and abdomen.

Group Type: ACTIVE_COMPARATOR

PET-CT

Intervention Type: DEVICE

50% of patients with unilateral pleural effusion will have performed a PET-CT

Interventions

Contrast-enhanced CT

50% of patients with unilateral pleural effusion will have performed a CE-CT

Intervention Type: DEVICE

PET-CT

50% of patients with unilateral pleural effusion will have performed a PET-CT

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Simon Reuter

OTHER

Sponsor Role: lead

Responsible Party

Simon Reuter

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Uffe Boedtger, MD, PhD

Role: STUDY_DIRECTOR

ubt@regionsjaelland.dk

Locations

Naestved Sygehus

Næstved, , Denmark

Countries

Denmark

Other Identifiers

Resp-REPEAT-SIRE

Identifier Type: -

Identifier Source: org_study_id