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Rational Approach to a Unilateral Pleural Effusion (REPEAT)

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ClinicalTrials.gov Identifier: NCT03272087
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : September 5, 2017
Sponsor:
Collaborators:
University of Southern Denmark
Odense University Hospital
Zealand University Hospital
University Hospital, Gentofte, Copenhagen
Bispebjerg Hospital
Rigshospitalet, Denmark
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.

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: Thoracoscopy Device: VATS (thoracoscopy) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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: Pleuroscopy
According to BTS guideline thoracoscopy is the next procedure for patients who remain undiagnosed despite PET-CT and attempts to obtain biopsies. Eligible patients will be randomised to pleuroscopy or VATS. Patients with inconclusive pleuroscopy will proceed to VATS.
Device: Thoracoscopy
50 % of patients will have performed af medical thoracoscopy (pleuroscopy)

Active Comparator: VATS (thoracoscopy)
According to BTS guideline thoracoscopy is the next procedure for patients who remain undiagnosed despite PET-CT and attempts to obtain biopsies. Eligible patients will be randomised to pleuroscopy or VATS. Patients with inconclusive pleuroscopy will proceed to VATS.
Device: VATS (thoracoscopy)
50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy




Primary Outcome Measures :
  1. Number of patients diagnosed with cancer [ Time Frame: 2 years ]
    (cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control).


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 1 month ]
    Questionnaire developed to assess the quality of life of cancer patients, QLQC 30

  2. Total costs [ Time Frame: 2 years ]
    calculated as costs patient-related, procedure-related, and overall

  3. Pain [ Time Frame: 2 years ]
    VAS scale

  4. Quality of life [ Time Frame: 1 month ]
    A standardised instrument for use as a measure of health outcome, EuroQol EQ-5D



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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): NCT03272087


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 Hospital Recruiting
Naestved, Denmark, 4700
Contact: Simon B Reuter, MD       sire@regionsjaelland.dk   
Principal Investigator: Simon B Reuter, MD         
Sponsors and Collaborators
Naestved Hospital
University of Southern Denmark
Odense University Hospital
Zealand University Hospital
University Hospital, Gentofte, Copenhagen
Bispebjerg Hospital
Rigshospitalet, Denmark
Investigators
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Study Director: Uffe Boedtger, MD, PhD Syddansk Universitet

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Responsible Party: Simon Reuter, Ph.d.-Student, Naestved Hospital
ClinicalTrials.gov Identifier: NCT03272087     History of Changes
Other Study ID Numbers: Resp-REPEAT-SIRE-2
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 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