Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions

This study has been completed.
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT00963716
First received: August 18, 2009
Last updated: August 20, 2009
Last verified: August 2009

August 18, 2009
August 20, 2009
November 2007
July 2009   (final data collection date for primary outcome measure)
Quality of pathological specimen [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00963716 on ClinicalTrials.gov Archive Site
Severity of bleeding [ Time Frame: During procedure ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions
Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions

A new electrocautery bronchoscopy biopsy forceps is now commercially available and may prevent bleeding following biopsy. Only one study used this device wherein the authors concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have a negative impact on the pathological samples, and that there was a statistically significant, albeit clinically insignificant reduction in bleeding score with hot biopsy forceps. Therefore, a randomized controlled study is required in which the hot and cold biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on histopathological diagnosis.

In recent years, a number of innovative non-thoracotomy techniques have been introduced for the diagnosis of indeterminate pulmonary disease but none has had greater impact on pulmonary medicine than flexible fiberoptic bronchoscopy. Since its introduction in 1968, fiberoptic bronchoscopy has become the procedure of choice for diagnosis and management of many bronchopulmonary disorders. It is accompanied by a low incidence of complications and can be performed satisfactorily by the transnasal approach without general anesthesia. Donlan et al, in 1978, and Ackart and colleagues, in 1983, demonstrated the safety of fiberoptic bronchoscopy as an outpatient procedure.

Transbronchial biopsy was first attempted, through a rigid bronchoscope in 1965, but was associated with a high occurrence of pneumothorax. Reports began to appear from 1974 onwards of lung biopsies done for diffuse pulmonary disease using the standard fiberoptic bronchoscope. Forceps biopsy through flexible bronchoscopy is commonly used to make the cytological or histological diagnosis. Of the procedures performed through bronchoscopy, forceps biopsy provides the best diagnostic yield of 71% to 93%.

A new electrocautery ''hot'' bronchoscopy biopsy forceps is now commercially available and may prevent bleeding following biopsy. Only one study used this device wherein the authors concluded that the use of hot biopsy forceps for endobronchial biopsy does not appear to have a negative impact on the pathological samples, and that there was a statistically significant (albeit clinically insignificant) reduction in bleeding score with hot biopsy forceps. However, limitations in this study were small sample size, use of hot and cold biopsy in the same patient as well as interval between the two biopsies were short due to which it is difficult to decide which technique has contributed to the bleeding. Therefore, a randomized controlled study is required in which the hot and cold biopsies are performed to evaluate the tissue effect of the hot biopsy forceps on histopathological diagnosis.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Endobronchial Growth
  • Lung Cancer
  • Device: Hot biopsy forceps
    Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
    Other Name: Hot biopsy
  • Device: Cold biopsy forceps
    Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
    Other Name: Cold biopsy
  • Experimental: Hot biopsy
    Hot biopsy i.e. Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
    Intervention: Device: Hot biopsy forceps
  • Active Comparator: Cold biopsy
    Cold biopsy i.e. Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
    Intervention: Device: Cold biopsy forceps
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. All patients undergoing routine bronchoscopic biopsy for various indications
  2. More than 18 years of age

Exclusion Criteria:

  1. Bleeding diathesis
  2. On pacemaker or implanted defibrillator
  3. On anticoagulation therapy
  4. Poor cardiopulmonary reserve
  5. Marked hypoxemia
  6. Uncooperative patient
  7. Enrollment in the previous study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00963716
Khan-1
No
Ajmal khan, Postgraduate Institute of Medical Education and Research
Postgraduate Institute of Medical Education and Research
Not Provided
Study Chair: Ashutosh N Aggarwal, MD, DM, FCCP PGIMER, Chandigrh
Postgraduate Institute of Medical Education and Research
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP