跳至主要内容
临床试验/NCT06892691
NCT06892691招募中不适用

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

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年3月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
98
试验地点
2
主要终点
Proportion of biopsies adequate for definitive diagnosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.)

排除标准

  • 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

研究组 & 干预措施

Pleuroscopy first

Active Comparator

Participants will undergo pleuroscopy first

干预措施: Pleuroscopy first (Procedure)

Thoracentesis first

Active Comparator

Participants will undergo thoracentesis first

干预措施: Thoracentesis first (Procedure)

结局指标

主要结局

Proportion of biopsies adequate for definitive diagnosis

时间窗: 6 months

Proportion of biopsies adequate for definitive diagnosis

次要结局

  • Time from initial visit with pulmonologist to diagnosis(6 months)
  • Time from initial visit with pulmonologist to procedure(6 months)
  • Time from initial procedure to diagnosis(6 months)
  • Time from initial visit with pulmonologist to seeing oncologist(6 months)
  • Time from initial visit with pulmonologist to starting treatment(6 months)
  • Time from seeing oncologist to starting treatment(6 months)
  • Frequency of procedure-related complications(6 months)
  • Frequency of additional diagnostic testing(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Udit Chaddha

Associate Professor of Medicine and Thoracic Surgery

Icahn School of Medicine at Mount Sinai

研究点 (2)

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