Rational Approach to a Unilateral Pleural Effusion2 (REPEAT)

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

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.

Study Overview

• Status: Terminated
• Conditions: Lung Neoplasms
• Intervention / Treatment: Device: Contrast-enhanced CT; Device: PET-CT

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Naestved, Denmark, 4700
    • Naestved Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CE-CT scanning; Contrast-enhanced CT scan of the thorax and abdomen.	Device: Contrast-enhanced CT; 50% of patients with unilateral pleural effusion will have performed a CE-CT
Active Comparator: PET-CT scanning; Positron-emission-CT scanning (low dose without contrast) of the thorax and abdomen.	Device: PET-CT; 50% of patients with unilateral pleural effusion will have performed a PET-CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of diagnostic thoracoscopies (either MT or VATS)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of derived investigations (i.e. gastroscopy, coloscopy)		2 years
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
Patient satisfaction and patient perceived discomfort	Using QLQC 30	2 years
Total costs calculated as costs patient-related, procedure-related, and overall		2 years
Total procedures before cancer-diagnosis (cancer = yes/no)		2 years
Patient satisfaction and patient perceived discomfort	EuroQol Q-5D a standardised instrument for use as a measure of health outcome	2 years

Collaborators and Investigators

• Sponsor: Simon Reuter
• Investigators: Study Director: Uffe Boedtger, MD, PhD, ubt@regionsjaelland.dk

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: July 12, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 15, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Thoracoscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Pleural Effusion
• Other Study ID Numbers: Resp-REPEAT-SIRE