Pleuroscopy First Versus Thoracentesis First in Patients With Suspected Malignant Pleural Effusions

Обзор

This is a randomized control trial of patients with suspected malignant pleural effusions to compare whether patients who have a thoracentesis or pleuroscopy (pleural biopsy) obtain an adequate biopsy, achieve a diagnosis, and begin cancer-directed therapy faster.

Подробное описание

This is a randomized control trial of patients with suspected malignant pleural effusions comparing patients who undergo either pleuroscopy or thoracentesis as the first diagnostic test. Both procedures are considered standard of care for this diagnosis but it is unknown which one provides more adequate biopsy samples and achieves faster diagnosis and shorter time to oncologic treatment. Currently, most patients undergo thoracentesis first and, if this is inadequate for diagnosis, they then undergo pleuroscopy for further biopsy samples. This study seeks to assess whether patients who undergo pleuroscopy as the first test obtain adequate biopsy samples and a faster path to further oncologic care compared to patients who undergo thoracentesis first. Patients will be recruited and randomized in a 1:1 manner.

Ultrasound is routinely used prior to the procedure and a chest x-ray is done after the procedure. Any other imaging will be determined by clinic need only. No imaging will be done for research purposes. No additional samples will be collected other than what is necessary for diagnostic purposes. In patients who have a non-diagnostic thoracentesis, the participants will be referred for pleuroscopy as the next diagnostic step. In the rare case that pleuroscopy does not achieve adequate diagnosis, the next step would be a liquid biopsy (non-invasive serologic testing for oncologic markers.) The need for liquid biopsy in participants in this study will be determined on a case-by-case basis depending on the clinical concern for malignancy.

Вмешательства

• Процедура Pleuroscopy first
  Pleuroscopies are performed under moderate sedation with local anesthesia. Through a 1-cm incision a camera is introduced into the pleural space and the space is inspected after draining all fluid. Targeted biopsies under direct visualization are obtained using forceps. The aspirated fluid and biopsies obtained are sent to the cytology and pathology laboratories for analysis.
• Процедура Thoracentesis first
  Thoracenteses are performed under local anesthesia with the insertion of a 5-8Fr catheter into the pleural space. The aspirated fluid obtained is sent to the cytology laboratory for analysis.

Первичные конечные точки

• Proportion of biopsies adequate for definitive diagnosis [Срок оценки: 6 months]

Вторичные конечные точки (8)

• Time from initial visit with pulmonologist to procedure [Срок оценки: 6 months]
• Time from initial procedure to diagnosis [Срок оценки: 6 months]
• Time from initial visit with pulmonologist to diagnosis [Срок оценки: 6 months]
• Time from initial visit with pulmonologist to seeing oncologist [Срок оценки: 6 months]
• Time from initial visit with pulmonologist to starting treatment [Срок оценки: 6 months]
• Time from seeing oncologist to starting treatment [Срок оценки: 6 months]
• Frequency of procedure-related complications [Срок оценки: 6 months]
• Frequency of additional diagnostic testing [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Referral for diagnostic pleural procedure.
• Age ≥ 18 years.
• Suspected malignant pleural effusion (Suggestive radiologic appearance (based on computed tomography or positron emission tomography) OR suspected cancer with associated effusion.)

Критерии исключения

• Inability to provide informed consent.
• Needs emergent drainage.
• Pleural effusion is known to be malignant.
• Suspected transudative, infectious or inflammatory effusion etiology.
• Having prior inconclusive/non-diagnostic thoracentesis or pleuroscopy.
• Patient is deemed by the clinical team to be more appropriate for VATS biopsy.
• Terminally ill patients in whom a diagnosis will not change management, or who is unlikely to be a candidate for oncological treatment due to significant comorbidities.
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 2 центра

• Mount Sinai West — New York
• Mount Sinai Hospital — New York

Идентификаторы

NCT: NCT06892691 · STUDY-24-00999

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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