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临床试验/NCT02405897
NCT02405897已完成不适用

A Study to Evaluate the Efficacy and Safety of Fenestrated Cup Forceps Versus Fenestrated Alligator Forceps for Performing Transbronchial Lung Biopsy in Patients With Sarcoidosis

Post Graduate Institute of Medical Education and Research, Chandigarh2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (histopathology)

研究概览

简要总结

Sarcoidosis is a systemic disease that results from granulomatous inflammation that involves multiple body organs. The diagnosis requires the presence of compatible clinicoradiological features along with histologic evidence that demonstrates non-caseating.1 Mediastinal lymph nodes and the lung parenchyma are the most commonly involved structures in sarcoidosis that can be sampled by, performing various bronchoscopic techniques. In a recent study the use of alligator forceps had a better yield in comparison to cup forceps. The investigators hypothesize that use of fenestrated alligator forceps in comparison to fenestrated cup forceps will yield larger samples, thereby improving the diagnostic yield and reducing the number of biopsy samples irrespective of the stage of sarcoidosis.

详细描述

Sarcoidosis is a multisystem disorder characterized by granulomatous inflammation involving various body organs. The diagnosis is based on presence of fulfillment of compatible clinicoradiological features and histologic evidence of non-caseating granuloma after exclusion of other known causes for granulomatous inflammation.1 As the lung and mediastinal lymph nodes are the most commonly involved structures in sarcoidosis, performing various bronchoscopic techniques like endobronchial biopsy (EBB), transbronchial biopsy (TBLB) and transbronchial needle aspiration (TBNA) are needed for tissue sampling. The diagnostic yield of TBLB in sarcoidosis in stage I and II varies from 31%2 to 69.6%.3 Transbronchial lung biopsy (TBLB) is performed with flexible bronchoscopy under the effect of local anesthesia and is the most commonly used bronchoscopic procedure to diagnose a wide array of lung diseases. It is performed as an outpatient procedure and is associated with minimal complications such as bleeding, pneumothorax and others.4 The procedure can be performed either as a blindly or under fluoroscopic guidance. The yield of TBLB varies depending upon the extent of disease, size of tissue, number of alveoli, number of biopsies, whether the sample floats or not and the size of forceps.5-12 The diagnostic yield of TBLB in sarcoidosis depends on the radiological stage and varies from 50-65% in stage I to 80 to 85% in stage II.13-15 The diagnostic yield also depends on the number of biopsy specimens (ten in stage I and 4-6 in stage II and III).9,10 In a recent study comprising of 44 patients with 176 samples, the use of alligator forceps yielded larger samples with lesser incidence of complications (major bleeding, alligator v/s cup forceps respectively, 1% v/s 5.7% and pneumothorax, 4.5 %v/s 9.1%). The investigators hypothesize that use of fenestrated alligator forceps in comparison to fenestrated cup forceps will yield larger samples, thereby improving the diagnostic yield and reducing the number of biopsy samples irrespective of the stage of sarcoidosis.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with a clinical diagnosis of sarcoidosis undergoing flexible bronchoscopy
  • age group of 12 to 90 years;
  • hemodynamically stable (systolic BP > 100 mm Hg without the need of vasopressors); and
  • ability to provide informed consent to participate in the study.

排除标准

  • hemoglobin less than 8 gm/dL;
  • platelet count of less than 80000;
  • bleeding diathesis;
  • prothrombin time or activated partial thrombin time prolongation of more than 6 seconds when compared to control;
  • baseline room air saturation less than 90%;
  • pregnancy; and,
  • failure to provide informed consent.

结局指标

主要结局

Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (histopathology)

时间窗: 12 months

Histopathology examination and findings

Diagnostic yield of fenestrated alligator versus fenestrated cup forceps for transbronchial lung biopsy (Size of the tissue)

时间窗: 12 months

Size of tissue: Size of the tissue will be visually assessed as small if it does not fill the cup, medium if it fills the cup and large if comes out of the cup

次要结局

  • Complication (Occurrence of pneumothorax)(12 months)
  • Complication (Occurrence of bleeding)(12 months)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ritesh Agarwal

Additional Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (2)

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