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Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions

18 Years
Not Enrolling
Endobronchial Growth, Lung Cancer

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Trial Information

Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Quality of pathological specimen

Outcome Time Frame:

4 hours

Safety Issue:


Principal Investigator

Ashutosh N Aggarwal, MD, DM, FCCP

Investigator Role:

Study Chair

Investigator Affiliation:

PGIMER, Chandigrh


India: Institutional Review Board

Study ID:




Start Date:

November 2007

Completion Date:

July 2009

Related Keywords:

  • Endobronchial Growth
  • Lung Cancer
  • endobronchial biopsy
  • bronchoscopy
  • interventional pulmonology
  • Lung Neoplasms