Rational Approach to a Unilateral Pleural Effusion2

NCT02834455 | Terminated

• 1 other identifier: Resp-REPEAT-SIRE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.PET/CT is comparable to CT alone
2. 2.VATS is comparable to pleuroscopy concerning hit rate, total investigations performed, time-to-diagnosis.

Conditions

Lung Neoplasms

Keywords

Thoracoscopy

Outcome Measures

Primary Outcomes (1)

• Number of diagnostic thoracoscopies (either MT or VATS)

  2 years

Secondary Outcomes (6)

• 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

  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

Study Arms (2)

CE-CT scanning

ACTIVE COMPARATOR

Contrast-enhanced CT scan of the thorax and abdomen.

Device: Contrast-enhanced CT

PET-CT scanning

ACTIVE COMPARATOR

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

Device: PET-CT

Interventions

Contrast-enhanced CT DEVICE

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

CE-CT scanning

PET-CT DEVICE

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

PET-CT scanning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with recurrent pleural effusion of unknown origin after a first pleural tap according to BTS guidelines.
• Indication for thoracoscopy according to BTS guidelines.
• Patients accept further investigation according to Danish and BTS guidelines.
• Have received oral and written consent and agreed.

You may not qualify if:

• Female patients: pregnancy or breastfeeding.
• Lack of language comprehension.
• Legally incompetent patients.
• Life expectancy less than 3 month.
• Contraindications to pleural tissue sampling.

Sponsors & Collaborators

• Simon Reuter: lead

Study Sites (1)

Naestved Sygehus

Næstved, 4700, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Uffe Boedtger, MD, PhD

  ubt@regionsjaelland.dk

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: July 15, 2016
• Study Start: May 1, 2015
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

DK (1)