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Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions

P

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Completed

Conditions

Endobronchial Growth
Lung Cancer

Treatments

Device: Hot biopsy forceps
Device: Cold biopsy forceps

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

168 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

168 participants in 2 patient groups

Hot biopsy
Experimental group
Description:
Hot biopsy i.e. Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
Treatment:
Device: Hot biopsy forceps
Cold biopsy
Active Comparator group
Description:
Cold biopsy i.e. Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps
Treatment:
Device: Cold biopsy forceps

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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