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
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cup forceps; Alligator forceps
Intervention type(s): Device; Device
Intervention description(s): In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using cup forceps; In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using alligator forceps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: flexible bronchoscopy; transbronchial lung biopsy; forceps