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Rational Approach to a Unilateral Pleural Effusion2 (REPEAT)

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ClinicalTrials.gov Identifier: NCT02834455
Recruitment Status : Recruiting
First Posted : July 15, 2016
Last Update Posted : August 31, 2017
Sponsor:
Information provided by (Responsible Party):
Simon Reuter, Naestved Hospital

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.

Condition or disease Intervention/treatment Phase
Lung Neoplasms Device: Contrast-enhanced CT Device: PET-CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Rational Approach to Unilateral Pleural Effusion in Patients Suspected of Malignancy. Efficacy, Pain, Quality of Life, and Economy
Study Start Date : May 2015
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of diagnostic thoracoscopies (either MT or VATS) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Number of derived investigations (i.e. gastroscopy, coloscopy) [ Time Frame: 2 years ]
  2. 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) [ Time Frame: 2 years ]
  3. Patient satisfaction and patient perceived discomfort [ Time Frame: 2 years ]
    Using QLQC 30

  4. Total costs calculated as costs patient-related, procedure-related, and overall [ Time Frame: 2 years ]
  5. Total procedures before cancer-diagnosis (cancer = yes/no) [ Time Frame: 2 years ]
  6. Patient satisfaction and patient perceived discomfort [ Time Frame: 2 years ]
    EuroQol Q-5D a standardised instrument for use as a measure of health outcome



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02834455


Contacts
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Contact: Simon B Reuter, MD sire@regionsjaelland.dk
Contact: Uffe Boedtger, MD, PhD ubt@regionsjaelland.dk

Locations
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Denmark
Naestved Sygehus Recruiting
Naestved, Denmark, 4700
Contact: Simon Reuter, MD       sire@regionsjaelland.dk   
Principal Investigator: Simon B Reuter, MD         
Sponsors and Collaborators
Simon Reuter
Investigators
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Study Director: Uffe Boedtger, MD, PhD ubt@regionsjaelland.dk

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Responsible Party: Simon Reuter, MD, Naestved Hospital
ClinicalTrials.gov Identifier: NCT02834455     History of Changes
Other Study ID Numbers: Resp-REPEAT-SIRE
First Posted: July 15, 2016    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017

Keywords provided by Simon Reuter, Naestved Hospital:
Thoracoscopy

Additional relevant MeSH terms:
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Pleural Effusion
Lung Neoplasms
Pleural Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases