CClinicalTrials.gg
CompletedNCT00963716Updated Aug 21, 2009

Hot and Cold Biopsy Forceps in the Diagnosis of Endobronchial Lesions

An interventional study of Hot biopsy forceps and Cold biopsy forceps in Endobronchial Growth and Lung Cancer, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-21.

Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Endobronchial Growth
  • Lung Cancer

Keywords

  • endobronchial biopsy
  • bronchoscopy
  • interventional pulmonology
03

In context

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    Hot biopsy

    Hot biopsy i.e. Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps

    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

    Device: Cold biopsy forceps

Interventions

  • DeviceHot biopsy forceps

    Endobronchial biopsies taken with the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps

    Also known as: Hot biopsy

  • DeviceCold biopsy forceps

    Endobronchial biopsies taken without the application of an electrocoagulation current by an electrocoagulation-capable biopsy forceps

    Also known as: Cold biopsy

06

What researchers measure

Primary outcomes

  1. Quality of pathological specimen

    Time frame: 4 hours

Secondary outcomes

  1. Severity of bleeding

    Time frame: During procedure

07

Study locations

1 site
  • Department of Pulmonary Medicine, PGIMER, India
    Chandigarh, UT 160012, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00963716
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
First posted
Aug 21, 2009
Start date
Nov 2007
Primary completion
Jul 2009
Completion
Jul 2009
Last update
Aug 21, 2009

Study contacts

Ashutosh N Aggarwal, MD, DM, FCCP
study chair · PGIMER, Chandigrh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion