Rational Approach to a Unilateral Pleural Effusion (REPEAT)

• ClinicalTrials.gov Identifier: NCT03272087
• Recruitment Status: Terminated
• First Posted: September 5, 2017
• Last Update Posted: December 17, 2020
• Sponsor: Naestved Hospital
• 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

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Study Start Date: May 2015
• Actual Primary Completion Date: December 15, 2020
• Actual Study Completion Date: December 15, 2020

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Denmark

Naestved Hospital

Naestved, Denmark, 4700

Sponsors and Collaborators

Naestved Hospital

University of Southern Denmark

Odense University Hospital

Zealand University Hospital

University Hospital, Gentofte, Copenhagen

Bispebjerg Hospital

Rigshospitalet, Denmark

Investigators

• Study Director: Uffe Boedtger, MD, PhD; Syddansk Universitet

More Information

• Responsible Party: Simon Reuter, Ph.d.-Student, Naestved Hospital
• ClinicalTrials.gov Identifier: NCT03272087
• Other Study ID Numbers: Resp-REPEAT-SIRE-2
• First Posted: September 5, 2017
• Last Update Posted: December 17, 2020
• Last Verified: December 2020

Keywords provided by Simon Reuter, Naestved Hospital:

Thoracoscopy

Additional relevant MeSH terms:

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